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

NCT06468579 | Completed Phase 1

• 1 other identifier: GT20029-CN-1001
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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

Conditions

Acne; Alopecia

Outcome Measures

Primary Outcomes (1)

• Evaluate the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] 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 Outcomes (13)

• To characterize the peak concentration (Cmax) of GT20029

  14 days

• To characterize the time to peak concentration (Tmax) of GT20029

  14 days

• To characterize the elimination half-life (t1/2) of GT20029

  14 days

• To characterize the area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) of GT20029

  14 days

• To characterize the area under the concentration-time curve from time zero to infinity (AUC0-∞) of GT20029

  14 days

Study Arms (2)

Experimental: GT20029

EXPERIMENTAL

Drug: GT20029

Placebo Comparator: GT20029 Placebo

PLACEBO COMPARATOR

Drug: GT20029 matching placebo

Interventions

GT20029 DRUG

Stage 1: GT20029 gel single ascending dose (1mg, 2mg, 5mg, 10mg) with 14 days washout window; Multi ascending dose (2mg QD, 2mg Q12h, 5mg QD, 5mg Q12h,10mg QD) for 14 consecutive days; Stage 2: GT20029 solution multi ascending dose (5mg QD, 10mg QD, 20mg QD) for 14 consecutive days;

Experimental: GT20029

GT20029 matching placebo DRUG

Stage 1: GT20029 gel matching placebo single ascending dose (1mg, 2mg, 5mg, 10mg) with 14 days washout window; Multi ascending dose (2mg QD, 2mg Q12h, 5mg QD, 5mg Q12h,10mg QD) for 14 consecutive days; Stage 2: GT20029 solution matching placebo multi ascending dose (5mg QD, 10mg QD, 20mg QD) for 14 consecutive days;

Placebo Comparator: GT20029 Placebo

Eligibility Criteria

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

You may qualify if:

• Patients who meet all of the following criteria may be included in this study:
• Subjects aged 18 to 60 years (including the boundary value), male or female;
• Male weight ≥ 50 kg, female weight ≥ 45 kg, body mass index (BMI) between 19 and 26 kg/m2 inclusive;
• The subject voluntarily participates in the clinical trial and signs the informed consent form, is able to communicate well with the investigator, and understands and complies with the requirements of this study;
• From signing the informed consent form to 3 months after the last dose, fertile female subjects or partners of fertile male subjects agree to and can take effective contraceptive measures, such as avoiding sex or using condoms, intrauterine device and other reliable contraceptive measures;
• Willing to use the investigational drug as required during the trial and refrain from using any other medication while receiving the investigational drug.

You may not qualify if:

• Patients who meet any of the following criteria will be excluded from the study:
• Previous allergy to the investigational drug and/or any excipients, or allergic constitution (such as two or more drugs, food or pollen allergy);
• Currently suffering from skin diseases requiring treatment and researchers believe that it is not suitable for enrollment, such as solar dermatitis, psoriasis, seborrheic dermatitis, rosacea, folliculitis, eczema and very severe acne;
• Previous or current suffering from the following diseases and researchers believe that cannot be enrolled, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism and bone and other system diseases and malignant tumors;
• Screening physical examination, vital signs, laboratory tests (blood routine, urine routine, blood biochemistry, coagulation function, etc.), 12-lead ECG results are abnormal and clinically significant, and have an impact on the evaluation of this trial;
• Subjects who plan to use various skin care products simultaneously on the back skin during the trial;
• Blood collection difficulties or cannot tolerate venipuncture, have a history of fainting needle halo blood;
• Blood donation or blood loss ≥ 200 mL within 3 months before screening, or plan to donate blood or blood components during the study or within 3 months after the end of the study;
• Smoking more than 5 cigarettes per day within 3 months before screening and those who cannot abstain from smoking throughout the trial;
• Drink more than 14 units of alcohol per week (1 unit of alcohol ≈ 360 mL beer or 45 mL of spirits with 40% alcohol content or 150 mL wine) within 3 months before signing the informed consent form, or have a positive breath alcohol test on the day before administration (breath alcohol content \> 0.0 mg/100 mL), or cannot abstain from alcohol during the trial;
• Patients who have been drinking excessive tea, coffee or caffeine-containing beverages for a long time (more than 8 cups a day, 1 cup = 200 mL);
• Consumption of any food or beverage containing caffeine, alcohol, xanthine or grapefruit ingredients (such as coffee, strong tea, chocolate, etc.) within 48 hours before the first dose;
• Use of any drugs (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.) or health products within 14 days or 7 half-lives (whichever is the longest) before the first dose;
• Use of any known liver enzyme inducer or liver enzyme inhibitor within 30 days before the first dose ;
• Use of drugs with the same target and mechanism (androgen receptor degraders) within 1 month before screening;

Sponsors & Collaborators

• Suzhou Kintor Pharmaceutical Inc,: lead

Study Sites (1)

Clinical Pharmacology Research Center, Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China

Location

MeSH Terms

Conditions

Acne Vulgaris; Alopecia

Condition Hierarchy (Ancestors)

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

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: May 27, 2024
• First Posted: June 21, 2024
• Study Start: July 25, 2021
• Primary Completion: August 15, 2022
• Study Completion: April 26, 2023
• Last Updated: October 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)