Study in Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of GT20029

NCT05428449 | Completed Phase 1 FDA Drug

• 1 other identifier: GT20029-US-1001
• Study Type: interventional
• Target: 123
• Locations: 1 country
• Sites: 2

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

Conditions

Androgenetic Alopecia; Acne Vulgaris

Outcome Measures

Primary Outcomes (6)

• Adverse event

  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

  Stage 1 is about 22 days and stage 2 is about 35 days

• Skin irritation assessments

  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)

  Stage 1 is about 22 days and stage 2 is about 35 days

• To characterize the PK 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 are: Stage 1 and 2: Cmax

  Stage 1 is about 22 days and stage 2 is about 35 days

• To characterize the PK 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 are: Stage 1 and 2: Tmax

  Stage 1 is about 22 days and stage 2 is about 35 days

• To characterize the PK 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: t1/2

  Stage 1 is about 22 days and stage 2 is about 35 days

• To characterize the PK AUC 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 and Stage 2: AUC

  Stage 1 is about 22 days and stage 2 is about 35 days

Study Arms (2)

GT20029

EXPERIMENTAL

Drug: GT20029 Gel

GT20029 Placebo

PLACEBO COMPARATOR

Drug: GT20029 Gel Placebo

Interventions

GT20029 Gel DRUG

Stage 1: One single dose Stage 2: One single dose per day (QD) or twice a day (BID) treatment over 14-day period

GT20029

GT20029 Gel Placebo DRUG

Stage 1: One single dose Stage 2: One single dose per day (QD) or twice a day (BID) treatment over 14-day period

GT20029 Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects who meet all of the following criteria can be enrolled into the study:
• For all(Cohort 1+ 2):
• Aged 18 to 60 years old;
• 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;
• Understand and agree to comply with planned study procedures;
• 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);
• Subjects are able to communicate well with the investigator and understand and comply with the requirements of the study
• Considered healthy by the Principal Investigator, based on a detailed medical history, full physical examination, clinical laboratory tests, 12-lead ECG and vital signs.
• For Cohort 1(single dose escalation):
• Healthy subjects, male or non-pregnant female;
• The subject's skin is healthy without damage or wound, tattoos and scars;
• For Cohort 2a(multiple dose escalation):
• Male;
• 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；
• Subject is willing to maintain the same hairstyle, hair length, and hair color throughout the study；

You may not qualify if:

• For all:
• Prior allergy to the investigational drug or any components;
• Use of drugs with the same target and mechanism as the investigational drug (androgen receptor degradation agent) within 1 month prior to screening;
• Any visible skin disease, damage or condition at the application site which, in the opinion of the investigator, could compromise subject safety and/or interfere with the evaluation of the test site reaction;
• Clinically significant history of gastrointestinal, cardiovascular, musculoskeletal, endocrine, hematologic, psychiatric, renal, hepatic, bronchopulmonary, neurologic, immunologic, lipid metabolism disorders, or drug hypersensitivity
• Known or suspected malignancy;
• Positive blood screen for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibody;
• A hospital admission or major surgery within 30 days prior to screening;
• Participation in any other investigational drug trial within 30 days prior to screening;
• A history of drug abuse within 6 months prior to screening or a positive screen for drugs of abuse;
• Subjects with an alcohol consumption of more than 14 units per week (1 unit of alcohol ≈ 360 mL of beer or 45 mL of spirits containing 40% alcohol or 150 mL of wine) within 3 months prior to signing the informed consent form, or subjects with a positive breath alcohol test result the day before dosing (breath alcohol content \> 0.0 mg/100 mL), or subjects cannot abstain from alcohol during the study;
• Subjects with a previous chronic consumption of excessive (more than 8 cups a day, 1 cup = 200 mL) tea, coffee, or caffeine-containing beverages;
• Subjects with a consumption of any food or beverages containing caffeine, alcohol, xanthine or grapefruit (e.g., coffee, strong tea, chocolate, etc.) within 48 hours prior to the first dose;
• Subjects who have difficulty in blood collection or cannot tolerate venipuncture or have a history of fear of needles and hemophobia;
• Subjects with a blood donation history or blood loss of ≥ 200 mL within 3 months prior to the study, or who plan to donate blood or blood components during the study or within 3 months after the end of the study;

Sponsors & Collaborators

• Suzhou Kintor Pharmaceutical Inc,: lead

Study Sites (2)

Velocity San Diego

San Diego, California, 91942, United States

Location

JBR Clinical Research Sharp

Salt Lake City, Utah, 84107, United States

Location

MeSH Terms

Conditions

Alopecia; Acne Vulgaris

Condition Hierarchy (Ancestors)

Hypotrichosis; Hair Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Acneiform Eruptions; Sebaceous Gland Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2022
• First Posted: June 23, 2022
• Study Start: February 10, 2022
• Primary Completion: October 27, 2022
• Study Completion: April 6, 2023
• Last Updated: August 14, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)