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Trial registered on ANZCTR


Registration number
ACTRN12624000239561
Ethics application status
Approved
Date submitted
10/01/2024
Date registered
11/03/2024
Date last updated
30/06/2024
Date data sharing statement initially provided
11/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Healthy Volunteer, Single Ascending Dose Study of TP-317
Scientific title
A Single Ascending dose to assess the safety, tolerability and pharmacokinetics of TP-317 under fasted conditions in adult healthy volunteers.
Secondary ID [1] 311227 0
TP317-001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inflammatory bowel disease 332434 0
Condition category
Condition code
Oral and Gastrointestinal 329121 329121 0 0
Inflammatory bowel disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study consists of 3 planned dose cohorts where each cohort will enrol a total of 8 participants of which 6 randomised to TP-317 treatment arm and 2 randomised to the placebo treatment arm. A total of 24 participants will be enrolled for this study.

The planned dosed cohorts are as follows:
Cohort 1 - Single oral dose of TP-317 10mg or Placebo tablets
Cohort 2- Single oral dose of TP-317 40mg or Placebo tablets
Cohort 3- Single oral dose of TP-317 80mg or Placebo tablets
Participants will be administered oral tablet(s) under fasted condition (no food or water 10 hours prior and no food for 4 hours post dose and no water for 2 hours post-dose) on Day 1 . A designated unblinded pharmacist or other qualified personnel at the clinical site will be responsible for administering the study medication
Each Cohort will be administered to a distinct group of participants and observed for 24 hours post dose before proceeding with dosing the other planned cohort participants. Safety review committee will determine to proceed with subsequent cohorts after reviewing the safety data.
Intervention code [1] 327685 0
Treatment: Drugs
Comparator / control treatment
Placebo will be the comparator. It will not be visually matching to the TP-317 investigational product. Placebo is a coated tablet. The placebo tablets are microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate, colloidal silicon dioxide and hypromellose.
Control group
Placebo

Outcomes
Primary outcome [1] 336954 0
To evaluate the safety and tolerability of TP-317 after a single oral dose administration
Timepoint [1] 336954 0
From the time participant signs the consent form to post study treatment safety follow up visit. on Day 14
Primary outcome [2] 336955 0
To evaluate the safety and tolerability of TP-317 after a single oral dose administration
Timepoint [2] 336955 0
ECG done at Screening, Day -1, Day 1 (pre-dose, 2 and 6 hrs post dosing) and Day 7
Vital signs (heart rate, blood pressure, respiratory rate and body temperature) will be taken Screening, Day -1.and on Days 1, 2, 3, 4 and at the in person follow up visit on D7.
Primary outcome [3] 336958 0
To evaluate the safety and tolerability of TP-317 after a single oral dose administration
Timepoint [3] 336958 0
Blood tests done at Screening, Day -1,, Days 2, 3, 4 and 7. post dosing
Secondary outcome [1] 430246 0
To evaluate the plasma PK of TP317 in healthy adult volunteers
Timepoint [1] 430246 0
Blood samples will be taken at the following time points for measurement of plasma TP-317 at pre-dose, 0.25, 0.5, 0.75, 1.0,1.25,1.5, 1.75, 2, 2.5, 3, 4, 8, 12 and 24 hours. post dose
Secondary outcome [2] 431667 0
To evaluate dose proportionality of PK of TP317
Timepoint [2] 431667 0
Blood samples will be taken at the following time points for measurement of plasma TP-317 at pre-dose, 0.25, 0.5, 0.75, 1.0,1.25,1.5, 1.75, 2, 2.5, 3, 4, 8, 12 and 24 hours. post dose

Eligibility
Key inclusion criteria
1. Males and females aged 18 to 65 years, inclusive at time of signing informed consent form
a. Female participants of childbearing potential may participate but are required to either abstain from sexual intercourse or use two highly effective methods of
contraception during the study, and for at least 30 days after the last dose of study medication.
b. Female participants must not be pregnant or breastfeeding at Screening or during the study period, and for 30 days after the final study drug administration.
c. Male participants with partners of childbearing potential may participate in the study if they had a vasectomy at least 6 months prior to randomization or if adequate contraception is used during the study and for at least 90 days after the last dose of study medication.
d. Sperm donation is prohibited during the study for at least 90 days and ova donation is prohibited during the study for at least 30 days after the last dose of study medication
2. Must meet the following laboratory criteria during Screening
a. Acceptable renal function defined as calculated creatinine clearance 90 mL/min/1.73 m2 or greater by Cockcroft-Gault:
b. Neutrophil count within the normal reference range
c. Platelet count > 100,000 µl
d. Eosinophil count within normal reference range
e. basophil count within normal reference range
f. Hemoglobin > normal reference range
g. PT within normal reference range
h. PTT within normal reference range
i. Serum creatinine within the normal reference range
3. Body Mass Index of 18 – 35 kg/m2 inclusive
4. Must agree to abstain from tobacco and/or cannabis use from Screening visit through safety follow-up visit.
5. Able to swallow numerous pills (i.e., study medication) at one time or in quick succession.
6. Willing and capable of giving written informed consent, which includes being able to comply with all aspects of the study treatment and testing schedule.
7. Will not participate in another interventional study while in this clinical study.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of consuming more than 14 units of alcoholic beverages per week within 6 months prior to screening or has a history of alcoholism or drug/chemical/ substance abuse within past 2 years prior to screening or the participant tests positive at the Screening or upon admission to the CRU for alcohol
2. History of substance abuse or dependency in the last 12 months, or a history of recreational intravenous drug use over the last 5 years (by self-declaration), or a positive toxicology screening panel (urine test including qualitative identification of amphetamines, barbiturates, benzodiazepines, THC, cocaine, and opiates) or positive testing identified by Phase 1-unit standard drug screening panel at Screening Visit or upon admission to study unit
3. Chronic use of cannabis and/or tobacco defined as daily use for greater than 3 months
4. Has greater than 6 months of chronic back pain, Grade 2 or greater, requiring chronic analgesic use, defined as requiring analgesics most days.
5. Any abnormal laboratory test results assessed as clinically significant by the Investigator.
6. Has alkaline phosphatase (ALP), aspartate transaminase (AST) and/or alanine transaminase (ALT) levels or total bilirubin >1.5 × the upper limit of normal (ULN),
Participants with a total bilirubin >2 x ULN that have a documented diagnosis of Gilbert’s syndrome may be enrolled
7. History or presence of any form of cancer within the 5 years prior to screening, with the exception of excised basal cell or squamous cell carcinoma of the skin, or carcinoma in
situ such as cervical or breast carcinoma that has been excised or resected completely and is without evidence of local recurrence or metastasis.
8. Has any medical condition (acute or chronic illness) or psychiatric condition that, in the opinion of the Investigator, could jeopardize or would compromise the participant’s
ability to participate in this study such as but not limited to: Impaired endocrine, thyroid, hepatic, respiratory or renal function, diabetes mellitus, coronary heart disease. Presence
or history of any significant hemorrhage, thromboembolic diseases or diatheses such as hypercoagulability, platelet disorder, or erythrocytosis.
9. Any surgical procedure (except for procedures determined by the investigator to be minor) within 4 weeks prior to the Screening Visit
10. Use of concomitant medication (including over the counter medication, health supplements, multivitamins and vitamin C, vitamin and omega-3 supplements, and herbal remedies such as St. John’s Wort extract) must be stopped at least 14 days prior to the first dose and not restarted until Day 7
11. Unable to stop use of proton pump inhibitors, H2 -receptor antagonists and antacids for 14 days prior to study drug administration through 7 days post study drug administration
12. Received a live vaccine within 4 weeks prior to Screening visit.
13. Know hypersensitivity to the study drug or it’s excipients thereof, or drug or other allergy that, in the opinion of the Investigator contraindicates participation in the study.
14. Intake of more than 6 cups of coffee or tea or equivalent of caffeinated beverages per day for > 3 months.
15. Positive test for hepatitis B virus (HBsAg), hepatitis C virus (HCV) antibodies, HIV1 or HIV2 at Screening Visit (participants testing positive for Hep B that have been treated be enrolled at investigator discretion)
16. Cannot have donated blood (quantified by 10% of participant’s anticipated blood volume) or had a blood transfusion within 3 months prior to study drug administration.
17. An active infection within 2 weeks of admission to CRU, determined by the investigator to be clinically significant.
18. Participation in any other study involving an investigational product within the last 30 days or 5 half-lives, whichever is greater, prior to the Screening Visit or during the study

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)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised 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
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Summary descriptive statistics will be presented for the endpoints. All assessments before the dose of study drug will be considered as baseline. Changes from baseline will also be summarized descriptively.
Continuous data will be summarized using the number of observations, mean, standard deviation (SD), coefficient of variation (CV%), median, and range, as appropriate. Categorical values will be summarized using frequencies (count) and proportions (%).
.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/03/2024
Actual
12/03/2024
Date of last participant enrolment
Anticipated
24/04/2024
Actual
30/05/2024
Date of last data collection
Anticipated
30/05/2024
Actual
13/06/2024
Sample size
Target
24
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25959 0
CMAX Clinical Research Pty Ltd - Adelaide
Recruitment postcode(s) [1] 41797 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 315849 0
Commercial sector/Industry
Name [1] 315849 0
Thetis Pharmaceuticals LLC .
Country [1] 315849 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Thetis Pharmaceuticals LLC
Address
Level 7, 330 Collins Street Melbourne, Victoria 3000, Australia
Country
United States of America
Secondary sponsor category [1] 317982 0
Commercial sector/Industry
Name [1] 317982 0
Novotech (Australia) Pty Ltd
Address [1] 317982 0
Country [1] 317982 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314392 0
Bellberry Human Research Ethics Committee
Ethics committee address [1] 314392 0
123 Glen Osmond Road, Eastwood, SA, 5063
Ethics committee country [1] 314392 0
Australia
Date submitted for ethics approval [1] 314392 0
13/12/2023
Approval date [1] 314392 0
16/01/2024
Ethics approval number [1] 314392 0

Summary
Brief summary
This is a first in human Single Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic of TP-317 (oral tablets) under fasted conditions in Adult Healthy Volunteers.

TP-317 is being developed to address the high unmet medical need for a safe, oral therapy for chronic treatment of mild to moderate inflammatory bowel disease (IBD)

This study consists of 3 planned dose cohorts. Each cohort will enroll a total of 8 participants with 6 randomized to TP-317 treatment arm and 2 randomized to the placebo treatment arm. Safety Review Committee will review the participant safety data as needed and determine dose escalation to the next cohort.

Participants in the study will be administered oral tablet(s) under fasted conditions, defined as no food or water 10 hours prior to oral dosing.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131418 0
Dr Richard Newman
Address 131418 0
CMAX Clinical Research Level 5, 18a North Terrace Adelaide South Australia 5000
Country 131418 0
Australia
Phone 131418 0
+61 408 880 766
Fax 131418 0
Email 131418 0
[email protected]
Contact person for public queries
Name 131419 0
Beverley Paperiello
Address 131419 0
Thetis Pharmaceuticals LLC 80 Plains Rd Essex CT 06426
Country 131419 0
United States of America
Phone 131419 0
+1 224 935 7007
Fax 131419 0
Email 131419 0
[email protected]
Contact person for scientific queries
Name 131420 0
Beverley Paperiello
Address 131420 0
Thetis Pharmaceuticals LLC 80 Plains Rd Essex CT 06426
Country 131420 0
United States of America
Phone 131420 0
+1 224 935 7007
Fax 131420 0
Email 131420 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.