NCT06692465

To Evaluate the Efficacy and Safety of GT20029 Solution in the Treatment of Androgenetic Alopecia (AGA) in Chinese Adult Males

A Multicenter, Randomized, Double-blind, Placebo -Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of GT20029 Solution in the Treatment of Androgenetic Alopecia (AGA) in Chinese Adult Males

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 180 (actual)
• Sponsor: Suzhou Kintor Pharmaceutical Inc, · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The study is a multicenter, randomized, double-blind, placebo-controlled phase II clinical study to evaluate the efficacy and safety of GT20029 solution.

Detailed description

GT20029 is a new investigational androgen receptor (AR) degrader for the treatment of androgenetic alopecia. A total of 180 adult male subjects with androgenetic alopecia (AGA) (according to Hamilton-Norwood classification IIIv, IV and V) were enrolled in this study. All subjects were randomly assigned in a 1:1:1:1:1:1ratio to investigational drug groups A, B, C and D and placebo groups E and F (i.e., 30 subjects in each group) and treated for 12 weeks at the specified dose and frequency for each group. The primary endpoint of the study is to evaluate the efficacy and safety of GT20029 solution in the treatment of androgenetic alopecia (AGA) in Chinese adult males and to determine the recommended dose for phase III trials.

Conditions

• Alopecia
• Male Pattern Hair Loss

Interventions

Type	Name	Description
DRUG	GT20029 Tincture	5mg (0.5%) and 10mg (1%) one single dose per day (QD) treatment over 12 weeks period; 5mg (0.5%) and 10mg (1%) twice per week (BIW) treatment, on every Monday and Thursday over 12 weeks period
DRUG	GT20029 matching placebo	5mg (0.5%) and 10mg (1%) matching placebo one single dose per day (QD) treatment over 12 weeks period; 5mg (0.5%) and 10mg (1%) matching placebo twice per week (BIW) treatment, on every Monday and Thursday over 12 weeks period

Timeline

• Start date: 2023-04-13
• Primary completion: 2023-12-14
• Completion: 2024-06-30
• First posted: 2024-11-18
• Last updated: 2024-11-18

Locations

1 site across 1 country: China