NCT06468579

To Evaluate the Safety, Tolerability and PK of GT20029 Gel and Solution in Healthy Subjects

A Randomized, Double-blind, Placebo-controlled Phase Ⅰ Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of GT20029 Gel and Solution for Single and Multi Dose External Administration in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 92 (actual)
• Sponsor: Suzhou Kintor Pharmaceutical Inc, · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

The study is a randomized, double-blind, vehicle-controlled, parallel group, phase 1 study to evaluate the Safety, Tolerability and PK of GT20029 in healthy subjects

Detailed description

GT20029 is a new investigational androgen receptor (AR) degrader for the treatment of acne and androgenetic alopecia. A total of 92 healthy subjects planned to be enrolled. It is divided into a single dose dosage stage and a multi dose dosage stage. This study comprised two stages. Stage 1 included single ascending dose (SAD) and multiple ascending dose (MAD) parts. In the SAD part, 28 subjects were first enrolled to evaluate GT20029 gel or the corresponding vehicle (placebo) at four dosing levels: 1 mg, 2 mg, 5 mg, and 10 mg. In the MAD part, 40 subjects were enrolled with five dosing levels: 2 mg QD, 2 mg Q12h, 5 mg QD, 5 mg Q12h, and 10 mg QD for 14 consecutive days. SAD subjects could transfer to the MAD QD dosing cohort at the same dosing level after a 14-day wash-out period if safety was confirmed by the investigator. In Stage 2, 24 subjects were enrolled to evaluate GT20029 solution or the corresponding vehicle (placebo) in the MAD part for 14 days with three dosing levels: 5 mg QD, 10 mg QD, and 20 mg QD. The administration site was an 8 cm by 8 cm area selected on the subjects' backs.

Conditions

• Acne
• Alopecia

Interventions

Type	Name	Description
DRUG	GT20029	Stage 1: GT20029 gel single ascending dose (1mg, 2mg, 5mg, 10mg) with 14 days washout window; Multi ascending dose (2mg QD, 2mg Q12h, 5mg QD, 5mg Q12h,10mg QD) for 14 consecutive days; Stage 2: GT20029 solution multi ascending dose (5mg QD, 10mg QD, 20mg QD) for 14 consecutive days;
DRUG	GT20029 matching placebo	Stage 1: GT20029 gel matching placebo single ascending dose (1mg, 2mg, 5mg, 10mg) with 14 days washout window; Multi ascending dose (2mg QD, 2mg Q12h, 5mg QD, 5mg Q12h,10mg QD) for 14 consecutive days; Stage 2: GT20029 solution matching placebo multi ascending dose (5mg QD, 10mg QD, 20mg QD) for 14 consecutive days;

Timeline

• Start date: 2021-07-25
• Primary completion: 2022-08-15
• Completion: 2023-04-26
• First posted: 2024-06-21
• Last updated: 2024-10-23

Locations

1 site across 1 country: China