Study in Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of GT20029

Recruiting at 1 trial location

Overseen By Clinical Operations

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Suzhou Kintor Pharmaceutical Inc,

Must not be taking: Androgen agents, Retinoids

Disqualifiers: Malignancy, HIV, Hepatitis, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

123 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a new medication called GT20029 on healthy people and those with hair loss or acne. Researchers want to see how the body processes the medication when applied to the skin and if it is safe.

Do I need to stop taking my current medications to join the trial?

Yes, you will need to stop taking any prescription or over-the-counter medications, as well as herbal supplements, at least 14 days before the trial starts. However, you can use acetaminophen in small amounts until 24 hours before the trial.

Eligibility Criteria

Inclusion Criteria

Aged 18 to 60 years old;

The subject or legally authorized representative give signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol;

Subjects with a weight of ≥ 50 kg for male, a weight of ≥ 45 kg for female, and a body mass index (BMI) between 19 and 30 kg/m2 (inclusive);

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical single and multiple ascending doses of GT20029 or placebo

8 weeks

Multiple visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• GT20029 Gel
• GT20029 Gel Placebo

Participant Groups

Group I: GT20029 Experimental Treatment 1 Intervention

Group II: GT20029 Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Suzhou Kintor Pharmaceutical Inc,

Lead Sponsor

Trials

18

Recruited

3,900+