AcnePhase 1NCT06989840
Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
A Phase 1 study testing TVB-3567 in people with Acne, run by Sagimet Biosciences Inc. at 6 sites in 2 countries.
Trial summary
This is a 4-part study. Part A will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (SAD) to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) biomarkers of TVB-3567 administered orally in healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- TVB-3567
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 3 Jun 2025to Feb 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy Participants (Parts A, B and C)
- Healthy, adult, male or female 18-55 years of age
- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2
- Medically healthy with no clinically significant medical history
- Understands the study procedures in the informed consent form (ICF) and willing and able to comply with the protocol
- Healthy Participants with Acne (Part D only)
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- Participants must meet all of the above criteria, as well as the following inclusion criteria to be eligible for participation in the study:
- BMI ≥18.0 and ≤37.0 kg/m2.
- Must be diagnosed with moderate to severe acne vulgaris
Who cannot join
- Healthy Participants (Parts A, B and C)
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds including over the counter acne products.
- Has a clinically significant ophthalmic examination finding
- Female participant of childbearing potential
- Unable to refrain from or anticipates the use of:
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- Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements
- Any topical anti-acne treatment on the face
- Any drugs known to be moderate or strong inducers of CYP3A4 enzymes, BCRP, and/or P gp, including St. John's Wort, beginning 28 days prior to the first dosing.
- Part C only: Any previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all-trans retinoic acid.
- Healthy Participants with Acne (Part D only)
- Participants must not be enrolled if they do not meet any of the above criteria, as well as the following exclusion criteria:
- Unable to refrain from or anticipates the use of:
- Any topical prescription or non-prescription anti-acne cleansers or treatments on the face, beginning 14 days prior to the first dosing.
- Tretinoins, including tazarotene, adapalene, trifarotene, tretinoin, photodynamic therapy, dermabrasion, or chemical peeling (on the face) beginning 4 weeks prior to the first dosing.
- Oral retinoid (isotretinoin) therapy beginning 6 months prior to the first dosing.
- Significant skin diseases
Trial locations and contacts
6 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
6 sites in 2 countries
Australia5 sites, 4 recruiting
- Recruiting
Emeritus Research
Botany, New South Wales, 2019
- Recruiting
Emeritus Research
Camberwell, Victoria, 3124
- Not yet recruiting
The Skin Hospital
Darlinghurst, New South Wales, 2010
- Recruiting
Fremantle Dermatology
Fremantle, Western Australia, 6160
- Completed
Nucleus Network
Melbourne, Victoria, 3004
About this study
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TVB-3567 in Healthy Participants With or Without Acne and to Assess the Effect of Food in Healthy Participants
This is a 4-part study. Part A will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (SAD) to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) biomarkers of TVB-3567 administered orally in healthy participants. Part B will be an open-label, 2-way crossover investigation to assess the effect of food on a single dose of TVB-3567 administered orally in healthy participants. Part C will be a randomized, double-blind, placebo-controlled investigation of multiple ascending doses (MAD) to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants. Part D will be an open-label investigation of two doses of TVB-3567 across two cohorts, to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants with moderate to severe acne.
- Conditions
- Acne
- Being tested
- TVB-3567, Placebo
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TVB-3567Drug
Orally administered capsule
PlaceboDrug
Orally administered capsule
| Study group | Role | What they receive |
|---|---|---|
| Part A (SAD in Healthy Participants) | Experimental | Not described Receives: Drug: TVB-3567; Drug: Placebo |
| Part B (Food Effect) | Experimental | Not described Receives: Drug: TVB-3567 |
| Part C (MAD in Healthy Participants) | Experimental | Not described Receives: Drug: TVB-3567; Drug: Placebo |
| Part D (MAD in Acne Participants) | Experimental | Not described Receives: Drug: TVB-3567; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Baseline to 7 to 8 days after dosing
Part B - Plasma AUC0-t in fasted and fed conditions
Area under the concentration-time curve from time zero until the last observed concentration
Measured: Baseline to Day 4
Part B - Plasma AUC0-inf in fasted and fed conditions
Area under the concentration-time curve from time zero to infinity
Measured: Baseline to Day 4
Part B - Plasma Cmax in fasted and fed conditions
Maximum concentration measurement in plasma
Measured: Baseline to Day 4
Part B - Incidence of adverse events (AEs) and serious adverse events (SAEs) under fasted and fed conditions
Measured: Baseline to 7 to 8 days after dosing
Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Baseline to 13 to 15 days after the last dose
Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs)
Measured: Baseline to 13 to 15 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start3 Jun 2025
- Primary completionJan 2027 (estimated)
- Study completionFeb 2027 (estimated)
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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 152 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sagimet Biosciences Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06989840
- Sponsor's protocol ID
- SB3567-CLIN-001
- Status last verified
- Oct 2026
- First submitted
- 16 May 2025
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of TVB-3567 in Healthy Participants With or Without Acne and to Assess the Effect of Food in Healthy Participants
- ClinicalTrials.gov ID
- NCT06989840
- Acronym / sponsor ID
- SB3567-CLIN-001
- Conditions
- Acne
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 152 participants (estimated)
- Lead sponsor
- Sagimet Biosciences Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 May 2025 (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.
This is a 4-part study. Part A will be a randomized, double-blind, placebo-controlled investigation of single ascending doses (SAD) to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) biomarkers of TVB-3567 administered orally in healthy participants. Part B will be an open-label, 2-way crossover investigation to assess the effect of food on a single dose of TVB-3567 administered orally in healthy participants. Part C will be a randomized, double-blind, placebo-controlled investigation of multiple ascending doses (MAD) to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants. Part D will be an open-label investigation of two doses of TVB-3567 across two cohorts, to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants with moderate to severe acne.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part A (SAD in Healthy Participants) | Experimental | Drug: TVB-3567, Drug: Placebo |
| Part B (Food Effect) | Experimental | Drug: TVB-3567 |
| Part C (MAD in Healthy Participants) | Experimental | Drug: TVB-3567, Drug: Placebo |
| Part D (MAD in Acne Participants) | Experimental | Drug: TVB-3567, Drug: Placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Healthy Participants (Parts A, B and C)
- Healthy, adult, male or female 18-55 years of age
- Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2
- Medically healthy with no clinically significant medical history
- Understands the study procedures in the informed consent form (ICF) and willing and able to comply with the protocol
Key exclusion criteria (17 listed)
- Healthy Participants (Parts A, B and C)
- History or presence of clinically significant medical or psychiatric condition or disease
- History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds including over the counter acne products.
- Has a clinically significant ophthalmic examination finding
- Female participant of childbearing potential
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 |
|---|---|---|
| TVB-3567Orally administered capsule | Drug | Part A (SAD in Healthy Participants), Part B (Food Effect), Part C (MAD in Healthy Participants), Part D (MAD in Acne Participants) |
| PlaceboOrally administered capsule | Drug | Part A (SAD in Healthy Participants), Part C (MAD in Healthy Participants), Part D (MAD in Acne Participants) |
Primary outcome
Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline to 7 to 8 days after dosing
Part B - Plasma AUC0-t in fasted and fed conditions
Time frame: Baseline to Day 4
Area under the concentration-time curve from time zero until the last observed concentration
Part B - Plasma AUC0-inf in fasted and fed conditions
Time frame: Baseline to Day 4
Area under the concentration-time curve from time zero to infinity
Part B - Plasma Cmax in fasted and fed conditions
Time frame: Baseline to Day 4
Maximum concentration measurement in plasma
Part B - Incidence of adverse events (AEs) and serious adverse events (SAEs) under fasted and fed conditions
Time frame: Baseline to 7 to 8 days after dosing
Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline to 13 to 15 days after the last dose
Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Baseline to 13 to 15 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
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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.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing TVB-3567 in people with Acne, run by Sagimet Biosciences Inc. at 6 sites in 2 countries.
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 9 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Australia, 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director ((650) 561-8600, SB3567-CLIN-001@sagimet.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs) (time frame: Baseline to 7 to 8 days after dosing). The study lists 7 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 21 Oct 2026.