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

Acne Clinical Trial

Official title: 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

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acne
• Alopecia

• NCT number: NCT06468579
• Study type: Interventional
• Source: Suzhou Kintor Pharmaceutical Inc,
• Status: Completed
• Phase: Phase 1
• Start date: July 25, 2021
• Completion date: April 26, 2023