Ignite Creation Date:
2024-07-17 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06468579
Status:
COMPLETED
Last Update Posted:
2024-06-21
First Post:
2024-05-27
Brief Title:
To Evaluate the Safety Tolerability and PK of GT20029 Gel and Solution in Healthy Subjects
Sponsor:
Suzhou Kintor Pharmaceutical Inc
Organization:
Suzhou Kintor Pharmaceutical Inc
Study Overview
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
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None