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Trial registered on ANZCTR


Registration number
ACTRN12623000416695
Ethics application status
Approved
Date submitted
20/03/2023
Date registered
27/04/2023
Date last updated
14/07/2024
Date data sharing statement initially provided
27/04/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
First-in-Human Study of Oral SDC-1801 in Healthy Adults and Adults with Plaque Psoriasis (Parts 1 and 2)
Scientific title
A First-in-human, Phase I, Randomised, 4-part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Food Effects, and Pharmacodynamics of Single Ascending and Multiple Ascending Oral Doses of SDC-1801 in Healthy Adults or Adults with Plaque Psoriasis (Parts 1 and 2 - Healthy Adults - SAD & MAD)
Secondary ID [1] 309209 0
SDC-1801-002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis 329353 0
Condition category
Condition code
Inflammatory and Immune System 326296 326296 0 0
Autoimmune diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A randomised, placebo controlled, dose-escalation, sequential group design is regarded as an appropriate standard design to initiate the cautious assessment of safety, tolerability, and PK of a new investigational product in healthy volunteers or adults with psoriasis. In Parts 1 and 2 of the study, a double-blind design is used to eliminate reporting bias and to assist in the reported evaluation of TEAEs.
Placebo is considered an appropriate control in the absence of an approved, active comparator with a mechanism of action comparable to that of SDC-1801, and in the likely absence of any sustained clinical response from the brief 14 days’ dosing with SDC-1801.
The study will be conducted in a single centre in Australia for Parts 1 and 2.
Parts 1 and 2 of the study consist of:
- A Screening Period 2-28 days prior to randomisation to ensure participants meet the inclusion/exclusion criteria
- A Study Period which include randomisation, study drug administration, and various assessments. The Study Period will begin 1 day prior to administration of the first dose of study drug.
- Follow-up conducted 14 ± 3 days after administration of the final dose of study drug.
GastroPlus® was used to predict the clearance of SDC-1801 in humans, which was predicted to be low, resulting in a predicted t½ of 17.1 hours.

Part 1, Single Ascending Dose of SDC-1801 in Healthy Adults.

A randomised, double-blind design, 3:1 ratio to a single dose of SDC-1801 or matching placebo administered as an oral capsule/s and consist of at least 6 sequential, ascending dose cohorts (Cohorts A, B, C, D, E, and F).
The participants in each cohort in Part 1 will be randomised in a 3:1 ratio to a single dose of SDC-1801 or matching placebo. SDC-1801 or placebo will be administered as an oral capsule/s after a fast of at least 8 hours. A sentinel dosing approach will be applied for each cohort whereby, initially, only 2 participants (1 for SDC-1801 and 1 for placebo) will be dosed on Study Day 1. On Study Day 2, if the review by the Principal Investigator and the Sponsor’s Medical Monitor of vital signs, TEAEs, and 24-hour post-dose laboratory safety data for the sentinel participants is satisfactory, then the remaining 6 participants in the cohort will start dosing the next day.
Post dosing, an oral examination will be performed to ensure all capsules have been swallowed by the participants.
Each cohort will consist of 8 healthy adults (a total of 48 participants).
The planned dose escalation sequence for SDC-1801/placebo in Part 1 is shown below:
Cohort A: starting dose = 5 mg
Cohort B: a dose not to exceed 10 mg
Cohort C: a dose not to exceed 30 mg
Cohort D: a dose not to exceed 75 mg
Cohort E: a dose not to exceed 150 mg
Cohort F: a dose not to exceed 300 mg.
Participants will be confined at the investigation site from Day -1 to approximately 120 hours after dosing (i.e. Day 6). A follow-up visit will take place 14 ± 3 days after the administration of study drug. Each participant will be in the study for approximately 6 weeks (Screening Visit to Follow-up Visit) and will receive 1 dose of SDC-1801 or placebo.

Part 2, Multiple Ascending Doses of SDC-1801 in Healthy Adults.

Part 2 will be randomised in a 3:1 ratio, double-blind design, and consist of at least 4 sequential, ascending dose of SDC-1801 or matching placebo cohorts (Cohorts A, B, C and D) administered as an oral capsule/s once daily (OD) or twice daily (BID) for 10 days.
Participants who have been enrolled in Part 1 of the study will not be allowed to participate in Parts 2 & 3 of the study.
Cohort A in Part 2 will only start after the Safety Review Committee (SRC) has taken place to review the available safety, tolerability, and PK data from Cohorts A, B, and C in Part 1, and members of the SRC have decided that it is appropriate to initiate Part 2 of the study and the dose that should be used for Cohort A in Part 2.
The study drug will be administered after an overnight fast of at least 8 hours and if a BID dose regimen is chosen, the second dose will be administered at approximately 8pm following a 4-hour fast. Post dosing, an oral examination will be performed to ensure all capsules have been swallowed by the participants.
Each cohort will consist of 8 healthy adults (a total of 32 participants).
In Part 2, a sentinel dosing approach will be applied for each cohort whereby, initially, only 2 participants (1 for SDC-1801 and 1 for placebo) will be dosed on Study Day 1. On Study Day 2, if the review by the Principal Investigator and the Sponsor's Medical Monitor of vital signs, TEAEs, and 24-hour post-dose laboratory safety data for the sentinel participants is satisfactory, then the remaining 6 participants in the cohort will start dosing the next day.
The starting dose of SDC-1801/placebo for cohort A in Part 2 will not exceed a daily dose of 75 mg. Dose selection for Cohorts B, C and D in Part 2 will be based on a review of all emergent safety, tolerability, and PK data from the preceding cohort(s). Each participant will be in the study for approximately 8 weeks and will receive a maximum of 10 or 19 doses of SDC-1801 or placebo.
The participants in each cohort will be randomised in a 3:1 ratio to multiple doses of SDC-1801 or matching placebo. SDC-1801 or placebo will be administered as an oral capsule/s once daily (OD) or twice daily (BID) for 10 days, based on the emergent safety and PK results from Part 1 of the study. On Day 1 and Day10 (to minimise any effect of food on PK assessments), the study drug will be administered after an overnight fast of at least 8 hours and if a BID dose regimen is chosen, the second dose will be administered at approximately 8pm following a 4-hour fast.
Between each dose cohort, a blinded analysis of safety, tolerability, and PK will be performed. If the dose for a cohort is judged to be safe by the SRC, then 7 days after completion of dosing in that cohort, dosing of the next cohort can begin.
The participants will be confined to the Clinical Pharmacology Unit (CPU) from mid-afternoon or evening of Day -1 to approximately 120 hours after the final dose of study drug (i.e. Day 15). A follow-up visit will take place 14 ± 3 days after administration of the final dose of study drug.
Between each dose cohort, a blinded analysis of safety, tolerability, and PK (up to 24 hours post-dose) will be performed. If the dose for a cohort is judged to be safe by the SRC, then 7 days after completion of dosing in that cohort, dosing of the sentinel participants in the next cohort can begin.
Intervention code [1] 325658 0
Treatment: Drugs
Comparator / control treatment
Placebo capsules are available to match the 5 mg, 10 mg, and 50 mg dosage strengths of SDC-1801 capsules. The placebo capsules are the same formulation as SDC-1801 capsules, but without SDC-1801 (i.e. they contain only the excipients of SDC-1801 capsules), and are a hydroxypropylmethylcellulose (HPMC) capsule comprising a VCaps® Plus Swedish orange body and cap.
Control group
Placebo

Outcomes
Primary outcome [1] 334161 0
To evaluate the safety and tolerability of a single ascending dose (SAD) and 10 days of multiple ascending doses (MAD) of oral SDC-1801 compared with placebo in healthy adults. Withdrawal information, and the reasons for withdrawal will be collected via the eCRF.
Timepoint [1] 334161 0
Screening Visit to Day 15 post-dose (Part 1 - SAD)
Screening Visit to Day 24 post-dose (Part 2 - MAD)
Primary outcome [2] 334453 0
Primary Outcome 1

Vital signs - Body temperature (via typmanic thermometer), pulse rate (via automated device), respiratory rate (via observation), systolic and diastolic blood pressure (via an automated device) and blood oxygen saturation (via pulse oximeter) will be measured at the following timepoints.
Timepoint [2] 334453 0
Part 1 (SAD)
- Screening
- Day -1
- Day 1: at Pre-dose, 2hrs, 4hrs and 12hrs
- Day 2-6 post-dose
- Day 15 post-dose (follow-up)

Part 2 (MAD)
- Screening
- Day -1
- Day 1 at Pre-dose, 2hrs, 4hrs and 12hrs
- Day 2-4 post first dose
- Day 7 post first dose
- Day 10-11 post first dose
- Day 13 post first dose
- Day 15 post first dose
- Day 24 post first dose (follow up).

In Part 1 and Part 2 of the study only, a single oxygen saturation reading will be taken using a pulse oximeter 3 hours after administration of the first dose of study drug on Day 1.
Primary outcome [3] 334454 0
Primary Outcome 2

ECGs will be recorded via the use of a standard 12 lead ECG machine, with measurements taken in triplicate, at the following time points.
Timepoint [3] 334454 0
Part 1 (SAD)

- Screening
- Day 1 at pre-dose, 1hr, 2hr, 3hr, 4hr, 8hr, and 12 hrs
- Day 2 post-dose
- Day 15 post-dose (follow-up).

Part 2 (MAD)

- Screening
- Day 1 at pre-dose, 1hr, 2hr, 4hr, 6hr, 8hr, and 12 hr following first dose
- Day 2 following second dose
- Day 10 post first dose on Day 1 at 0hr, 1hr, 2hr, 3hr, 4hr, 8hr, 12hr following dosing on Day 10
- Day 11 post first dose
- Day 24 post first dose (follow-up).
Secondary outcome [1] 419614 0
Primary Outcome 3

Treatment Emergent Adverse Events (TEAEs) will be recorded throughout the study.

TEAEs include, but are not limited to:

• Any symptom or condition not previously reported by the participant (medical history).
• Any abnormal laboratory test results (e.g. haematology, clinical chemistry, or urinalysis) or other safety assessments (e.g. ECG, vital signs), including those that worsen from baseline, considered clinically significant in the medical and scientific judgment of the Investigator.
• An exacerbation of a pre-existing symptom or condition.
• A significant increase in frequency or intensity of a pre-existing episodic event or condition.
• A drug interaction.
• Signs, symptoms, or the clinical sequelae of a suspected overdose of either a study drug or a concomitant medication. Overdose per se will not be reported as a TEAE/SAE unless it is an intentional overdose taken with possible suicidal/self-harming intent. Such overdoses should be reported regardless of sequelae.
• A condition first detected or diagnosed after study drug administration even though it may have been present prior to the start of the study.

TEAEs will be elucidated by non-leading verbal questioning of the participant to inquire about TEAE occurrences, along with observation of clinically significant abnormal laboratory results.

TEAEs will be recorded at the following timepoints
Timepoint [1] 419614 0
Part 1 (SAD)
- Screening
- Day -1
- Day 1 Pre-dose, and then hourly.
- Day 2-6 post-dose
- Day 15 post-dose (follow up).

Part 2 (MAD)
- Screening
- Day -1
- Day 1: Pre dose, and then at 0, 1, 1.5, 2, 3, 4, 6. 8, and 12hrs following first dose
- Day 2-9 post first dose
- Day 10 post first dose at 0, 1, 1.5, 2, 3, 4, 6, 8, and 12hrs following dosing on Day 10.
- Day 11-15 post first dose
- Day 24 post first dose (follow up).
Secondary outcome [2] 420752 0
Primary Outcome 4

Clinical Laboratory samples of blood and urine (for haematology, blood chemistry and urinalysis) will be collected and measured at the following timepoints.
Timepoint [2] 420752 0
Part 1 (SAD)
- Screening
- Pre-dose (day 1)
- Day 2-3 post-dose
- Day 6 post-dose
- Day 15 post-dose (follow up).

Part 2 (MAD)
- Screening
- Pre-dose (day 1)
- Day 2-3 post first dose
- Day 9-10 post first dose
- Day 12-13 post first dose
- Day 15 post first dose
- Day 24 post first dose (follow up).
Secondary outcome [3] 420764 0
Secondary Outcome

To evaluate the pharmacokinetics (PK) of SDC-1801 in plasma and urine after SAD and MAD administration of oral SDC-1801 compared with placebo in healthy adults,

All PK analyses will be conducted using the PK Population.

The following parameters, where appropriate, will be determined for SDC-1801 and its metabolites by noncompartmental analysis using individual concentration-time profiles in plasma and urine:

• Plasma: Cmax, Tmax, C24, Cav, AUC24, AUC from the time of dosing to time t (AUC0-t), AUC0-8, t½, terminal rate constant, Rac.

• Urine: Ae tau and CL r.
• Dose-standardized parameters (Cmax/dose, C24h/dose or CT/dose, AUC/dose and Ae%).

Additional PK parameters may be calculated if appropriate.
Timepoint [3] 420764 0
Part 1 (SAD)
Plasma PK taken at:
-Day 1 pre-dose, and at 1, 1.5, 2, 3, 4, 6, 8, and 12hrs post dose
- Day 2-6 post dose

Urinary PK collection at:
- Day 1: 4, 8, 12 and 24hrs post-dose

Part 2 (MAD)
Plasma PK taken at:
- Day 1; pre-dose, 1, 1.5, 2, 3, 4, 6, 8, and 12hrs post first dose
- Day 2-9 post first dose
- Day 10 post first dose at 0, 1, 1.5, 2, 3, 4, 6, 8, 12hrs following dosing on Day 10
- Day 11-15 post first dose

Urinary PK collection at:
- Day 1: 4, 8, 12 and 24hrs post dose

Eligibility
Key inclusion criteria
Inclusion Criteria for Parts 1 & 2

Participants are eligible to be included in the study only if all of the following criteria apply:

1. Able and willing to comply with the protocol requirements and to sign the informed consent form (ICF) prior to any screening evaluations.
2. Healthy males and females between 18-55 years of age on date of signing ICF.
3. Body mass index (BMI) between 18-32 kg/m2, inclusive.
4. Participants in good health based upon the results of a medical history, physical examination, vital signs, 12-lead ECG, and fasting clinical laboratory safety tests as determined by the Investigator.
5. Aspartate aminotransferase (AST)/serum glutamic oxaloacetic transaminase (SGOT) and
alanine aminotransferase (ALT)/serum glutamic pyruvic transaminase (SGPT) values less than or equal to 1.3 x upper limit of normal (ULN). Total bilirubin less than or equal to 1.3 x ULN; participants with a history of Gilbert's syndrome may have a direct bilirubin measured and would be eligible for this study provided the direct bilirubin is less than or equal to ULN.
6. Participant must be able and willing to comply with restrictions on prior and concomitant medication.
7. Negative for severe acute respiratory syndrome coronavirus-2 infection.
8. Non-smoker and not using any nicotine-containing products
9. Negative screen for drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabis, cocaine, opiates, methadone, tricyclic antidepressants) and alcohol.
10. Must agree to avoid prolonged exposure to the sun and avoid other ultraviolet light sources (e.g. tanning beds) during the study period and for 7 days after the last dose of study drug.
11. Adherence to effective contraception or are proven post-menopausal
12. No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB) or history of untreated or inadequately treated latent or active TB infection
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Known hypersensitivity to investigational medicinal product (IMP) ingredients or history of
a significant allergic reaction to IMP ingredients as determined by the Investigator
2. Positive serology for hepatitis B virus surface antigen (HBsAg) or hepatitis C virus (HCV),
or history of hepatitis from any cause with the exception of hepatitis A
3. History of or a current immunosuppressive condition (e.g. human immunodeficiency virus
[HIV] infection).
4. Having any illness, judged by the Investigator as clinically significant, in the 3 months prior to the first dose of study drug.
5. Current clinically significant infection or clinically significant infection within 6 months of
first dose of study drug
6. History of chronic or recurrent infectious disease within the last 2 years.
7. Symptomatic herpes zoster or herpes simplex within 12 weeks of first dose of study drug, or more than one episode of local herpes zoster, or a history of disseminated zoster.
8. Pregnant or breast feeding participants.
9. Presence or sequelae of gastrointestinal, liver, or kidney (estimated creatinine clearance
less than or equal to 80 mL/min, using the Cockcroft-Gault formula; if calculated creatinine clearance is less than or equal to 80mL/min a 24-hour urine collection may be performed to assess renal function) disease,
10. History of malignancy within the past 5 years (except for basal cell carcinoma of the skin
that has been treated and with no evidence of recurrence)
11. Clinically significant abnormalities detected on 12-lead ECG
12. Clinically significant abnormalities detected on vital signs.
13. Significant blood loss (including blood donation [>500 mL]), or transfusion of any blood
product within 12 weeks prior to Screening.
14. Treatment with any drug known to have a potential for major organ toxicity in the last
3 months before the first dose of this study drug.
15. Treatment with any medication (including over-the-counter and/or prescription medicines [including hormonal replacement therapy for postmenopausal participants], dietary supplements, nutraceuticals, recreational drugs, vitamins and/or herbal supplements) within the last 2 weeks or 5 half-lives of that drug (whichever is longer) prior to the first dose of this study drug. Occasional paracetamol (maximum dose of 2 g/day and 10 g/2 weeks) is permitted for use at any time during the study.
16. Vaccination with live virus, attenuated live virus, or any live viral components within the
6 weeks prior to the first dose of study drug or is to receive these vaccines during study
treatment or within 8 weeks following completion of study treatment.
17. Routine household contact (during study treatment or for 8 weeks following completion of study treatment) with individuals who have received vaccination with live virus or
attenuated live virus.
18. Active drug or alcohol abuse
19. Consumption of a large quantity of caffeinated coffee or tea (>6 cups per day) or equivalent.
20. Consumption of grapefruit, grapefruit juice, or citrus fruits within 7 days prior to the first dose of study drug and until collection of the final PK blood sample.
21. Current or previous participation in another investigational research study where the
participant has received a drug, drug/device, or biologic within 12 weeks or 5 of its
half-lives (whichever is longer) prior to the first dose of this study drug.
22. Investigator or other study site staff who is directly involved in the conduct of the study and their relatives.
23. Any condition or circumstances that in the opinion of the Investigator may make a
participant unlikely or unable to complete the study or comply with study procedures and
requirements.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Treatment allocation will be managed by the unblinded site Pharmacy using a randomisation list provided by the Sponsor. At the point of randomisation, participants will be assigned to the next available randomisation number in sequence.

In Part 1 & 2 of the study, participants will be randomised to SDC-1801 or matching placebo in a 3:1 ratio.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Healthy Volunteer SAD
Healthy Volunteer MAD
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
All data collected in this study will be documented using summary tables, figures, and subject data listings.

Absolute values and change from baseline in physical examinations, clinical laboratory
evaluations, vital signs assessments, and ECG parameters will be summarised by visit and by treatment group. The frequency of participants with safety laboratory results outside of normal reference ranges will be tabulated by treatment and visit. Abnormal physical examination findings will be listed.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
4/06/2023
Actual
5/06/2023
Date of last participant enrolment
Anticipated
7/05/2024
Actual
24/05/2024
Date of last data collection
Anticipated
4/06/2024
Actual
21/06/2024
Sample size
Target
80
Accrual to date
Final
79
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24294 0
Nucleus Network - Melbourne
Recruitment postcode(s) [1] 39839 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 313393 0
Commercial sector/Industry
Name [1] 313393 0
Sareum Limited
Country [1] 313393 0
United Kingdom
Primary sponsor type
Commercial sector/Industry
Name
Pharmaceutical Solutions Australia Pty Ltd
Address
C/O - BDO
Level 11, 1 Margaret Street
Sydney NSW 2000
Country
Australia
Secondary sponsor category [1] 315157 0
Commercial sector/Industry
Name [1] 315157 0
Pampisford Pty Ltd
Address [1] 315157 0
Level 17, HWT Tower, 40 City Road, Southbank VIC 3006
Country [1] 315157 0
Australia
Other collaborator category [1] 282586 0
Commercial sector/Industry
Name [1] 282586 0
Pharmaceutical Solutions Australia Pty Ltd
Address [1] 282586 0
C/O - BDO
Level 11, 1 Margaret Street
Sydney NSW 2000
Country [1] 282586 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312610 0
Alfred Health Ethics Committee
Ethics committee address [1] 312610 0
55 Commercial Road
Melbourne, Vic 3004
Ethics committee country [1] 312610 0
Australia
Date submitted for ethics approval [1] 312610 0
29/03/2023
Approval date [1] 312610 0
04/05/2023
Ethics approval number [1] 312610 0

Summary
Brief summary
SDC-1801 is a small molecule tyrosine kinase 2 (TYK2)/janus kinase 1 (JAK1) inhibitor entering clinical development for the treatment of participants with inflammatory diseases such as psoriasis. The nonclinical good laboratory practice (GLP) toxicology and safety pharmacology studies indicate that it is appropriate to cautiously assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SDC-1801 in the context of a well-designed, first-in-human (FIH) study.

It is reasonable to say that the risk of adverse events (AEs) for JAK inhibitors are broadly similar to those for other biological disease modifying antirheumatic drug (bDMARD) classes. However, concealed within this, there are also important differences between JAK inhibitors and bDMARDs. Tofacitinib and baricitinib have AE profile characteristics that distinguish them from the other bDMARD classes, with signals including an increased risk of herpes zoster reactivation, elevation in lipids, and decreases in haemoglobin and lymphocytes (including natural killer cells).

Based on available nonclinical data, SDC-1801 is a potent and selective small molecule TYK2/JAK1 inhibitor currently in development for inflammatory and autoimmune indications, and it has the potential to have an improved safety profile and similar efficacy profile compared with other JAK inhibitors and specific TYK2 inhibitors.

A randomised, placebo controlled, dose-escalation, sequential group design is regarded as an appropriate standard design to initiate the cautious assessment of safety, tolerability, and PK of a new investigational product in healthy volunteers.

The chosen sample sizes will provide sufficient data to make an initial assessment of the safety, tolerability, and PK of SDC-1801.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125278 0
Dr Sam Francis
Address 125278 0
Nucleus Network
Level 5, Burnet Tower
89 Commercial Road
Melbourne, Victoria, 3004
Country 125278 0
Australia
Phone 125278 0
+61 466 640 801
Fax 125278 0
+61 3 9001 5810
Email 125278 0
[email protected]
Contact person for public queries
Name 125279 0
Tim Mitchell
Address 125279 0
Sareum Ltd
2A Langford Arch
Cambridge CB22 3FX
United Kingdom
Country 125279 0
United Kingdom
Phone 125279 0
+44 1223 497703
Fax 125279 0
Email 125279 0
[email protected]
Contact person for scientific queries
Name 125280 0
John Reader
Address 125280 0
Sareum Ltd
2A Langford Arch
Cambridge CB22 3FX
United Kingdom
Country 125280 0
United Kingdom
Phone 125280 0
+441223497704
Fax 125280 0
Email 125280 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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