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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03099603




Registration number
NCT03099603
Ethics application status
Date submitted
14/03/2017
Date registered
4/04/2017
Date last updated
27/07/2020

Titles & IDs
Public title
A Study of HTD1801 in Healthy Subjects
Scientific title
A First in Human, Randomized, Double-Blind Study to Assess Safety, Tolerability, and Pharmacokinetics of Single, Ascending Doses of HTD1801 in Healthy Subjects
Secondary ID [1] 0 0
1801.PCT002
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Primary Sclerosing Cholangitis 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Infection 0 0 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - HTD1801

Placebo comparator: 0.5g - single dose of placebo to 2 healthy subjects or 0.5g HTD1801 to 6 healthy subjects

Placebo comparator: 1.0g - single dose of placebo to 2 healthy subjects or 1.0g HTD1801 to 6 healthy subjects

Placebo comparator: 2.0g - single dose of placebo to 2 healthy subjects or 2.0g HTD1801 to 6 healthy subjects

Placebo comparator: 4.0g - single dose of placebo to 2 healthy subjects or 4.0g HTD1801 to 6 healthy subjects


Treatment: Drugs: HTD1801
A small molecular compound for the treatment of primary sclerosing cholangitis
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single dose
Timepoint [1] 0 0
up to Day 30
Secondary outcome [1] 0 0
HTD1801 plasma concentration levels after single dose
Timepoint [1] 0 0
96 hours
Secondary outcome [2] 0 0
Pharmacokinetics (PK) of HTD1801 in plasma after single dose - peak plasma concentration (Cmax)
Timepoint [2] 0 0
96 hours
Secondary outcome [3] 0 0
PK of HTD1801 in plasma after single dose - area under the plasma concentration vs. time curve (AUC)
Timepoint [3] 0 0
96 hours
Secondary outcome [4] 0 0
PK of HTD1801 in plasma after single dose - time to peak plasma concentration (Tmax)
Timepoint [4] 0 0
96 hours
Secondary outcome [5] 0 0
PK of HTD1801 in plasma after single dose - half life (T1/2)
Timepoint [5] 0 0
96 hours

Eligibility
Key inclusion criteria
1. Age =18 to = 50 years
2. Body mass index (BMI) =18.0 to = 30.0 kg/m2
3. Current non-user of any nicotine containing products (>6 months)
4. Females must be non-pregnant and non-lactating, and either surgically sterile (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy, bilateral oophorectomy) or post-menopausal for =12 months. The site will try to retrieve medical records to document the sterility, however, the absence of records will not exclude screening the participant. If medical records cannot be obtained, serum and urine pregnancy testing will be conducted. Postmenopausal status will be confirmed through testing of FSH levels = 40 IU/mL at screening for amenorrheic female participants <50 years of age.

Males must be surgically sterile (>30 days since vasectomy with no viable sperm), abstinent or if engaged in sexual relations with a child-bearing potential, the participant and his partner must be using an acceptable, highly effective, contraceptive method from Screening and for a period of 60 days after the last dose of Study Drug. Acceptable methods of contraception are the use of condoms and an effective contraceptive for the female partner that includes: surgical sterilization (e.g., bilateral tubal ligation), hormonal contraception, or intrauterine contraception/device). The Principal Investigator will assess the adequacy of methods of contraception on a case-by-case basis.
5. Ability to provide written informed consent.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Participation in an investigational drug study within 30 days prior to dosing or 5 half-lives within the last dose of investigational product whichever is longer.
2. Current use of any prescription or over-the-counter (OTC) medications, including herbal products and supplements, within 14 days prior to Day 1 or 5 half-lives, whichever is longer. [Use of =2 g per day of paracetamol (acetaminophen) is allowed prior to and during the study at Investigator discretion. The reason for use must be listed either in the subject's baseline information or as an adverse event.]
3. Any use of non-steroid anti-inflammatory drugs (NSAIDs) within 7 days prior to dosing.
4. History of any serious adverse reaction or hypersensitivity to any of the product components.
5. Use of parenterally administered proteins or antibodies within 12 weeks of screening. (Note: Influenza vaccine will be allowed)
6. Glucose-6-phosphate dehydrogenase(G6PD) deficiency.
7. History of weight loss > 5% in the 8 weeks prior to screening.
8. History of any active infection, other than mild viral illness, within 30 days prior to dosing.
9. History of alcohol or illicit drug abuse as judged by the Investigator within approximately 1 year
10. Use of any nicotine-containing product within 6 months prior to Screening or at any time during the study and follow-up as confirmed by urine cotinine screening.
11. Presence of clinically significant medical history, physical, laboratory, or ECG findings that, in the opinion of the Investigator, may potentially compromise the safety of the subject, or interfere with any aspect of study conduct or interpretation of results.

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)
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
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
24/03/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
3/10/2017
Sample size
Target
Accrual to date
Final
32
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Nucleus Network Limited - Melbourne
Recruitment postcode(s) [1] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
HighTide Biopharma Pty Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a randomized, double blind, single center, ascending single dose study to evaluate the safety, tolerability, and PK of HTD1801.
Trial website
https://clinicaltrials.gov/study/NCT03099603
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Janet Wong, Doctor
Address 0 0
Nucleus Network Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03099603