Androgenetic AlopeciaPhase 1NCT05428449
Study in Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of GT20029
A Phase 1 study testing GT20029 Gel in people with Androgenetic Alopecia and Acne Vulgaris, run by Suzhou Kintor Pharmaceutical Inc, at 2 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Androgenetic Alopecia, Acne Vulgaris
- What is being tested?
- GT20029 Gel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 123 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Feb 2022to 6 Apr 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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);
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- 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
Who cannot join
- 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
Show all 47Show fewer
- 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;
- Subject has any skin pathology or condition that, in the investigator's opinion, could interfere with the evaluation of the investigational drug or requires use of interfering topical, systemic (e.g., uncontrolled thyroid disease, certain genetic disorders that involve hair growth or patterns), or surgical therapy;
- Subject has current or recent history (within 12 months) of hair weaves, non-breathable wigs, or hair bonding;
- Subject had scalp hair transplants at any time;
- Subject has a history or active hair loss due to diffuse telogen effluvium, alopecia areata, scarring alopecia, trichotillomania, or conditions/diseases other than AGA;
- Subject has a current or recent history (within six months) of severe dietary or weight changes or has a history of eating disorder(s); if such has resulted in hair loss refer to exclusion criterion #5;
- Any disorder, including but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the Investigator and could affect the safety of the subject throughout the study
- For Cohort 2b(acne)
- Subject has greater than two (2) facial nodules.
- Subject has nodulocystic acne.
- Subject has facial hair that could interfere with the study assessments in the opinion of the investigator.
- Subject has used any of the following topical anti-acne preparations or procedures on the face:
- Topical anti-acne treatments including, but not limited to, over-the-counter (OTC) acne cleansers or treatments, benzoyl peroxide, antibiotics, azelaic acid, sulfa based products, corticosteroids and salicylic acid within two (2) weeks of the initiation of treatment.
- Retinoids, including tazarotene, adapalene, tretinoin, within four (4) weeks of the initiation of treatment.
- Light treatments, microdermabrasion, or chemical peels within eight (8) weeks of the initiation of treatment.
- Subject has used the following systemic anti-acne medications:
- Corticosteroids (including intramuscular and intralesional injections) within four (4) weeks of the initiation of treatment. Inhaled, intranasal, or ocular corticosteroids are allowed if use is stable (stable use is defined as dose and frequency unchanged for at least four (4) weeks prior to the initiation of treatment).
- Antibiotics within four (4) weeks of the initiation of treatment with the exception of five (5) days or less of antibiotic therapy during this period, BUT with no antibiotics use permitted within one (1) week prior to the initiation of treatment.
- Spironolactone within eight (8) weeks of the initiation of treatment with the exception of five (5) days or less of spironolactone therapy during this period, BUT with no spironolactone use permitted within one (1) week prior to the initiation of treatment.
- Retinoid therapy within six (6) months of the initiation of treatment.
- Other systemic therapy which may materially affect the subject's acne in the opinion of the investigator.
- For female subjects:
- Pregnant, lactating women, or women who plan to become pregnant during the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
JBR Clinical Research Sharp
Salt Lake City, Utah, 84107
Velocity San Diego
San Diego, California, 91942
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of GT20029 Following Topical Single and Multiple Ascending Dose Administration
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
- Being tested
- GT20029 Gel, GT20029 Gel Placebo
- Medical subject headings
- Alopecia, Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT20029 GelDrug
Stage 1: One single dose Stage 2: One single dose per day (QD) or twice a day (BID) treatment over 14-day period
GT20029 Gel PlaceboDrug
Stage 1: One single dose Stage 2: One single dose per day (QD) or twice a day (BID) treatment over 14-day period
| Study group | Role | What they receive |
|---|---|---|
| GT20029 | Experimental | Not described Receives: Drug: GT20029 Gel |
| GT20029 Placebo | Placebo comparator | Not described Receives: Drug: GT20029 Gel Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Stage 1 is about 22 days and stage 2 is about 35 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2022
- Study start10 Feb 2022
- Primary completion27 Oct 2022
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Androgenetic AlopeciaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05428449
- Sponsor's protocol ID
- GT20029-US-1001
- Status last verified
- Aug 2023
- First submitted
- 15 Mar 2022
- Last updated
- 14 Aug 2023
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Dose Escalation Study in Subjects to Evaluate the Safety, Tolerability and Pharmacokinetics of GT20029 Following Topical Single and Multiple Ascending Dose Administration
- ClinicalTrials.gov ID
- NCT05428449
- Acronym / sponsor ID
- GT20029-US-1001
- Conditions
- Androgenetic Alopecia, Acne Vulgaris
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,Industry (pharma, biotech, devices)
- Study start
- 10 Feb 2022 (actual)
- Primary completion
- 27 Oct 2022 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 23 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GT20029 | Experimental | Drug: GT20029 Gel |
| GT20029 Placebo | Placebo comparator | Drug: GT20029 Gel Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (20 listed)
- Subjects who meet all of the following criteria can be enrolled into the study:
Key exclusion criteria (47 listed)
- Subjects will be excluded from study entry if any of the following exclusion criteria are present at screening:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GT20029 GelStage 1: One single dose Stage 2: One single dose per day (QD) or twice a day (BID) treatment over 14-day period | Drug | GT20029 |
| GT20029 Gel PlaceboStage 1: One single dose Stage 2: One single dose per day (QD) or twice a day (BID) treatment over 14-day period | Drug | GT20029 Placebo |
Primary outcome
Adverse event
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GT20029 Gel in people with Androgenetic Alopecia and Acne Vulgaris, run by Suzhou Kintor Pharmaceutical Inc, at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 47 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse event (time frame: Stage 1 is about 22 days and stage 2 is about 35 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2023; AzTrials last refreshed its copy on 6 Nov 2026.