To Evaluate the Safety, Tolerability and PK of GT20029 Gel and Solution in Healthy Subjects
NCT Number: NCT06468579
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Acne|Alopecia
Interventions: DRUG: GT20029|DRUG: GT20029 matching placebo
Sponsor: Suzhou Kintor Pharmaceutical Inc,
Sex: ALL
Age: ADULT
Enrollment: 92
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2021-07-25
Completion Date: 2023-04-26
Locations: Clinical Pharmacology Research Center, Huashan Hospital, Fudan University, Shanghai, Shanghai, 200040, China

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

Primary Outcome Measures: Evaluate the safety of GT20029 for single dose and multi dose topical administration in healthy subjects., Incidence of Treatment Emergent Adverse Events, as assessed by Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, V2.1, 14 days
Secondary Outcome Measures: To characterize the peak concentration (Cmax) of GT20029, The plasma concentration time data for GT20029 and its metabolite will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analyses. The primary PK parameters of interest following dose administration is: Stage 1, single-dose administration, Cmax, 14 days|To characterize the time to peak concentration (Tmax) of GT20029, The plasma concentration time data for GT20029 and its metabolite will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analyses. The primary PK parameters of interest following dose administration is: Stage 1, single-dose administration, Tmax, 14 days|To characterize the elimination half-life (t1/2) of GT20029, The plasma concentration time data for GT20029 and its metabolite will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analyses. The primary PK parameters of interest following dose administration is: Stage 1, single-dose administration, t1/2, 14 days|To characterize the area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) of GT20029, The plasma concentration time data for GT20029 and its metabolite will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analyses. The primary PK parameters of interest following dose administration is: Stage 1, single-dose administration, AUC0-t, 14 days|To characterize the area under the concentration-time curve from time zero to infinity (AUC0-∞) of GT20029, The plasma concentration time data for GT20029 and its metabolite will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analyses. The primary PK parameters of interest following dose administration is: Stage 1, single-dose administration, AUC0-∞, 14 days|To characterize the area under the terminal elimination rate constant (λz) of GT20029, The plasma concentration time data for GT20029 and its metabolite will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analyses. The primary PK parameters of interest following dose administration is: Stage 1, single-dose administration, λz, 14 days|To characterize the area under the apparent volume of distribution (Vd/F) of GT20029, The plasma concentration time data for GT20029 and its metabolite will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analyses. The primary PK parameters of interest following dose administration is: Stage 1, single-dose administration, Vd/F, 14 days|To characterize the area under the apparent clearance (CL/F) of GT20029, The plasma concentration time data for GT20029 and its metabolite will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analyses. The primary PK parameters of interest following dose administration is: Stage 1, single-dose administration, CL/F, 14 days|To characterize the area under the concentration-time curve at steady state (AUCss) of GT20029, The plasma concentration time data for GT20029 and its metabolite will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analyses. The primary PK parameters of interest following dose administration are: Stage 1, multi-ascending dose and Stage 2, AUCss, 14 days|To characterize the peak concentration at steady state (Cmax,ss) of GT20029, The plasma concentration time data for GT20029 and its metabolite will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analyses. The primary PK parameters of interest following dose administration are: Stage 1, multi-ascending dose and Stage 2, Cmax,ss, 14 days|To characterize the trough concentration at steady state (Cmin,ss) of GT20029, The plasma concentration time data for GT20029 and its metabolite will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analyses. The primary PK parameters of interest following dose administration are: Stage 1, multi-ascending dose and Stage 2, Cmin,ss, 14 days|To characterize the time to peak concentration at steady state (Tmax,ss) of GT20029, The plasma concentration time data for GT20029 and its metabolite will be analyzed using noncompartmental methods. Actual dosing and sampling times will be used for analyses. The primary PK parameters of interest following dose administration are: Stage 1, multi-ascending dose and Stage 2, Tmax,ss, 14 days|Evaluate the ratio of systemic exposure between the gel and solution formulation., Evaluate the ratio of systemic exposure between the gel and solution formulation by using GT20029 gel as a reference., 14 days