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

Completed · Phase 1 · Has a placebo group

Conditions studied: Androgenetic Alopecia, Acne Vulgaris

In brief

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

Key facts

Study ID

NCT05428449

Run by

Suzhou Kintor Pharmaceutical Inc,

People needed

123

Starts

2022-02-10

Expected to finish

2023-04-06

Last updated by the study team

2023-08-14

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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；
• For cohort 2b (multiple dose escalation)
• Male or non-pregnant female;
• Subjects clinically diagnosed with grade I-III acne vulgaris as per the Pillsbury International Modified Classification, and with an IGA score of 2-3;
• 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.
• Negative COVID-19 results within 7 days prior first dosing

You may not qualify if…

• Subjects will be excluded from study entry if any of the following exclusion criteria are present at screening:
• 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;
• Subjects who smoked more than 5 cigarettes per day within 3 months before the study and who could not stop smoking during the entire study;
• Donation or blood collection of more than 1 unit (approximate 450 mL) of blood (or blood products) or acute loss of blood during the 90 days prior to screening;
• Use of prescription or over-the-counter (OTC) medications, and herbal (including St John's Wort, herbal teas, garlic extracts) within 14 days prior to dosing (Note: Use of acetaminophen at < 3g/day is permitted until 24 hours prior to dosing);
• An unwillingness to use highly effective contraceptive measures if engaging in sexual intercourse with a partner of childbearing potential. Highly effective measures include use of a condom and spermicide and, for female partners, use of an intrauterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, progesterone subdermal implants, or a tubal ligation, and men or women who are unwilling to use contraception throughout the study and until 1 month after the end of the study.
• Subjects who are employees or related personnel of the investigator, study site, sponsor, and contract research organization;
• Subjects who have other conditions that may affect compliance in the opinion of the investigator, or who are unable to participate in the study for his/her own reasons;
• Subjects who are unable to communicate or cooperate with health care professional due to neurological, psychiatric or language disorders
• For Cohort 2a (subjects with alopecia):
• Subject has any dermatological disorders of the scalp in the target region with the possibility of interfering with the application of the investigational drug, such as fungal or bacterial infections, seborrheic dermatitis, psoriasis, eczema, folliculitis, scars, or scalp atrophy;

Where it is running

• Velocity San Diego — San Diego, California, United States
• JBR Clinical Research Sharp — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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