Acne Vulgaris, Androgenetic Alopecia
Conditions
Brief summary
A randomized, double-blind, placebo-controlled, parallel group, dose escalation study to evaluate the safety, tolerability and pharmacokinetics (PK) of GT20029 following topical single ascending dose in healthy subjects and multiple ascending dose administration in subjects with androgenetic alopecia(AGA) or acne
Interventions
DRUGGT20029 Gel
Stage 1: One single dose Stage 2: One single dose per day (QD) or twice a day (BID) treatment over 14-day period
DRUGGT20029 Gel Placebo
Stage 1: One single dose Stage 2: One single dose per day (QD) or twice a day (BID) treatment over 14-day period
Sponsors
Suzhou Kintor Pharmaceutical Inc,
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Subjects who meet all of the following criteria can be enrolled into the study: 1. For all(Cohort 1+ 2): 1. Aged 18 to 60 years old; 2. The subject or legally authorized representative gives signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol; 3. Understand and agree to comply with planned study procedures; 4. Subjects with a weight of ≥ 50 kg for male, a weight of ≥ 45 kg for female, and a body mass index (BMI) between 19 and 30 kg/m2 (inclusive); 5. Subjects are able to communicate well with the investigator and understand and comply with the requirements of the study 6. Considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs. 2. For Cohort 1(single dose escalation): 1. Healthy subjects, male or non-pregnant female; 2. The subject's skin is healthy without damage or wound, tattoos and scars; 3. For Cohort 2a(multiple dose escalation): 1. Male; 2. Have a clinical diagnosis of mild to moderate androgenetic alopecia; rating IIIv, IV and V on the modified Norwood Hamilton Scale, with a history of ongoing hair loss； 3. Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study； 4. For cohort 2b (multiple dose escalation) 1. Male or non-pregnant female; 2. Subjects clinically diagnosed with grade I-III acne vulgaris as per the Pillsbury International Modified Classification, and with an IGA score of 2-3; 3. Subject has used the same type and brand of make-up, other facial products (exclusive of RX/OTC acne cleansers) and hair products (e.g., shampoo, gel, hair spray, mousse, etc.) for at least one (1) month prior to the Baseline Visit and agrees to continue his/her other general skin and hair care products and regimen for the entire study. 5. Negative COVID-19 results within 7 days prior first dosing
Exclusion criteria
* Subjects will be excluded from study entry if any of the following
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse event | Stage 1 is about 22 days and stage 2 is about 35 days | 8 subjects in a group do not experience any Grade 3 or higher AEs (assessed by NAIDS 2017 v2.1) within 7 days after the last dose, the dose can be escalated to the next. Dose-escalation will be stopped if any of the following occur: * a SAE occurs in one or more active-treated subjects that is considered probably or definitely related to study drug * ≥50% subjects receiving active treatment experience a severe non-serious adverse event that is considered probably or definitely related to study drug * ≥50% subjects receiving active treatment experience, for example, a Grade 2 or higher cardiac or bone marrow adverse event or Grade 3 or higher adverse event for other systems |
| Skin irritation assessments | Stage 1 is about 22 days and stage 2 is about 35 days | Dose-escalation will be stopped if any of the following occur: • ≥2 subjects receiving active treatment in a group experience one (or more) severe local skin reaction (score = 5, 6 or 7) |
| To characterize the PK Cmax of GT20029 | Stage 1 is about 22 days and stage 2 is about 35 days | 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 and 2: Cmax |
| To characterize the PK Tmax of GT20029 | Stage 1 is about 22 days and stage 2 is about 35 days | 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 and 2: Tmax |
| To characterize the PK t1/2 of GT20029 | Stage 1 is about 22 days and stage 2 is about 35 days | 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: t1/2 |
| To characterize the PK AUC of GT20029 | Stage 1 is about 22 days and stage 2 is about 35 days | 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 and Stage 2: AUC |
Countries
United States
Outcome results
None listed