A Study of HTD1801 in Healthy Subjects

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03099603
• Date of registration: 14/03/2017
• Prospective Registration: Yes
• Primary sponsor: HighTide Biopharma Pty Ltd
• 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
• Date of first enrolment: March 24, 2017
• Target sample size: 32
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03099603
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 1

Countries of recruitment

Australia

Contacts

• Name: Janet Wong, Doctor
• Affiliation: Nucleus Network Ltd

Key inclusion & exclusion criteria

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.

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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: All

Health Condition(s) or Problem(s) studied

Primary Sclerosing Cholangitis

Intervention(s)

Drug: HTD1801

Primary Outcome(s)

Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) after single dose [Time Frame: up to Day 30]

Secondary Outcome(s)

Pharmacokinetics (PK) of HTD1801 in plasma after single dose - peak plasma concentration (Cmax) [Time Frame: 96 hours]

PK of HTD1801 in plasma after single dose - time to peak plasma concentration (Tmax) [Time Frame: 96 hours]

PK of HTD1801 in plasma after single dose - half life (T1/2) [Time Frame: 96 hours]

HTD1801 plasma concentration levels after single dose [Time Frame: 96 hours]

PK of HTD1801 in plasma after single dose - area under the plasma concentration vs. time curve (AUC) [Time Frame: 96 hours]

Secondary ID(s)

1801.PCT002

Source(s) of Monetary Support

Please refer to primary and secondary sponsors