AcnePhase 1NCT06468579
To Evaluate the Safety, Tolerability and PK of GT20029 Gel and Solution in Healthy Subjects
A Phase 1 study testing GT20029 in people with Acne and Alopecia, run by Suzhou Kintor Pharmaceutical Inc, at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- GT20029
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteChina
- Study dates
- 25 Jul 2021to 26 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
- 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.
Who cannot join
- 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;
Show all 24Show fewer
- 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;
- Drug addiction and drug abuse test one or more positive, 1 year before the test drug abuse/dependence history or drug history;
- Human immunodeficiency virus (HIV) antibody, hepatitis B surface antigen, hepatitis C virus antibody, treponema pallidum antibody test positive;
- Pregnant or lactating women or female subjects with positive blood pregnancy during screening period;
- Subjects with back application site skin damage or wounds, tattoos or scars;
- Planned to participate in strenuous exercise during the trial, including body contact exercise or collision exercise;
- Major surgery within 3 months before screening, or plan to undergo major surgery during the trial;
- Participating or participating in any drug or medical device clinical trial within 3 months before screening;
- Unable to communicate or cooperate with medical staff due to neurological, psychiatric or language disorders;
- Other conditions that the investigator considers unsuitable for participating in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Clinical Pharmacology Research Center, Huashan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200040
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Phase Ⅰ Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of GT20029 Gel and Solution for Single and Multi Dose External Administration in Healthy Subjects
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
Read the detailed description
GT20029 is a new investigational androgen receptor (AR) degrader for the treatment of acne and androgenetic alopecia.
A total of 92 healthy subjects planned to be enrolled. It is divided into a single dose dosage stage and a multi dose dosage stage.
This study comprised two stages. Stage 1 included single ascending dose (SAD) and multiple ascending dose (MAD) parts. In the SAD part, 28 subjects were first enrolled to evaluate GT20029 gel or the corresponding vehicle (placebo) at four dosing levels: 1 mg, 2 mg, 5 mg, and 10 mg. In the MAD part, 40 subjects were enrolled with five dosing levels: 2 mg QD, 2 mg Q12h, 5 mg QD, 5 mg Q12h, and 10 mg QD for 14 consecutive days. SAD subjects could transfer to the MAD QD dosing cohort at the same dosing level after a 14-day wash-out period if safety was confirmed by the investigator.
In Stage 2, 24 subjects were enrolled to evaluate GT20029 solution or the corresponding vehicle (placebo) in the MAD part for 14 days with three dosing levels: 5 mg QD, 10 mg QD, and 20 mg QD. The administration site was an 8 cm by 8 cm area selected on the subjects' backs.
- Being tested
- GT20029, GT20029 matching placebo
- Medical subject headings
- Acne Vulgaris, Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT20029Drug
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;
GT20029 matching placeboDrug
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;
| Study group | Role | What they receive |
|---|---|---|
| Experimental: GT20029 | Experimental | Not described Receives: Drug: GT20029 |
| Placebo Comparator: GT20029 Placebo | Placebo comparator | Not described Receives: Drug: GT20029 matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (13)
To characterize the peak concentration (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 is: Stage 1, single-dose administration, Cmax
Measured: 14 days
To characterize the time to peak concentration (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 is: Stage 1, single-dose administration, Tmax
Measured: 14 days
To characterize the elimination half-life (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, single-dose administration, t1/2
Measured: 14 days
To characterize the area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) 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, single-dose administration, AUC0-t
Measured: 14 days
To characterize the area under the concentration-time curve from time zero to infinity (AUC0-∞) 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, single-dose administration, AUC0-∞
Measured: 14 days
To characterize the area under the terminal elimination rate constant (λz) 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, single-dose administration, λz
Measured: 14 days
To characterize the area under the apparent volume of distribution (Vd/F) 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, single-dose administration, Vd/F
Measured: 14 days
To characterize the area under the apparent clearance (CL/F) 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, single-dose administration, CL/F
Measured: 14 days
To characterize the area under the concentration-time curve at steady state (AUCss) 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, multi-ascending dose and Stage 2, AUCss
Measured: 14 days
To characterize the peak concentration at steady state (Cmax,ss) 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, multi-ascending dose and Stage 2, Cmax,ss
Measured: 14 days
To characterize the trough concentration at steady state (Cmin,ss) 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, multi-ascending dose and Stage 2, Cmin,ss
Measured: 14 days
To characterize the time to peak concentration at steady state (Tmax,ss) 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, multi-ascending dose and Stage 2, Tmax,ss
Measured: 14 days
Evaluate the ratio of systemic exposure between the gel and solution formulation.
Evaluate the ratio of systemic exposure between the gel and solution formulation by using GT20029 gel as a reference.
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start25 Jul 2021
- Primary completion15 Aug 2022
- Study completion26 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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
- 92 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
- NCT06468579
- Sponsor's protocol ID
- GT20029-CN-1001
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 23 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Phase Ⅰ Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of GT20029 Gel and Solution for Single and Multi Dose External Administration in Healthy Subjects
- ClinicalTrials.gov ID
- NCT06468579
- Acronym / sponsor ID
- GT20029-CN-1001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Suzhou Kintor Pharmaceutical Inc,Industry (pharma, biotech, devices)
- Study start
- 25 Jul 2021 (actual)
- Primary completion
- 15 Aug 2022 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 21 Jun 2024 (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.
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
Detailed description
GT20029 is a new investigational androgen receptor (AR) degrader for the treatment of acne and androgenetic alopecia.
A total of 92 healthy subjects planned to be enrolled. It is divided into a single dose dosage stage and a multi dose dosage stage.
This study comprised two stages. Stage 1 included single ascending dose (SAD) and multiple ascending dose (MAD) parts. In the SAD part, 28 subjects were first enrolled to evaluate GT20029 gel or the corresponding vehicle (placebo) at four dosing levels: 1 mg, 2 mg, 5 mg, and 10 mg. In the MAD part, 40 subjects were enrolled with five dosing levels: 2 mg QD, 2 mg Q12h, 5 mg QD, 5 mg Q12h, and 10 mg QD for 14 consecutive days. SAD subjects could transfer to the MAD QD dosing cohort at the same dosing level after a 14-day wash-out period if safety was confirmed by the investigator.
In Stage 2, 24 subjects were enrolled to evaluate GT20029 solution or the corresponding vehicle (placebo) in the MAD part for 14 days with three dosing levels: 5 mg QD, 10 mg QD, and 20 mg QD. The administration site was an 8 cm by 8 cm area selected on the subjects' backs.
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 |
|---|---|---|
| Experimental: GT20029 | Experimental | Drug: GT20029 |
| Placebo Comparator: GT20029 Placebo | Placebo comparator | Drug: GT20029 matching placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (24 listed)
- 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;
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 |
|---|---|---|
| GT20029Stage 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; | Drug | Experimental: GT20029 |
| GT20029 matching placeboStage 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; | Drug | Placebo Comparator: GT20029 Placebo |
Primary outcome
Evaluate the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of GT20029 for single dose and multi dose topical administration in healthy subjects.
Time frame: 14 days
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
13 secondary outcomes
To characterize the peak concentration (Cmax) of GT20029
Time frame: 14 days
To characterize the time to peak concentration (Tmax) of GT20029
Time frame: 14 days
To characterize the elimination half-life (t1/2) of GT20029
Time frame: 14 days
To characterize the area under the concentration-time curve from time zero to the last measurable concentration (AUC0-t) of GT20029
Time frame: 14 days
To characterize the area under the concentration-time curve from time zero to infinity (AUC0-∞) of GT20029
Time frame: 14 days
To characterize the area under the terminal elimination rate constant (λz) of GT20029
Time frame: 14 days
To characterize the area under the apparent volume of distribution (Vd/F) of GT20029
Time frame: 14 days
To characterize the area under the apparent clearance (CL/F) of GT20029
Time frame: 14 days
To characterize the area under the concentration-time curve at steady state (AUCss) of GT20029
Time frame: 14 days
To characterize the peak concentration at steady state (Cmax,ss) of GT20029
Time frame: 14 days
To characterize the trough concentration at steady state (Cmin,ss) of GT20029
Time frame: 14 days
To characterize the time to peak concentration at steady state (Tmax,ss) of GT20029
Time frame: 14 days
Evaluate the ratio of systemic exposure between the gel and solution formulation.
Time frame: 14 days
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 23 Oct 2024.
- 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.
1 site 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 in people with Acne and Alopecia, run by Suzhou Kintor Pharmaceutical Inc, at 1 site in China.
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 6 inclusion and 24 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 23 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
Evaluate the Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of GT20029 for single dose and multi dose topical administration in healthy subjects. (time frame: 14 days). 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 23 Oct 2024.