NCT06989840 Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
| NCT ID | NCT06989840 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Sagimet Biosciences Inc. |
| Condition | Acne |
| Study Type | INTERVENTIONAL |
| Enrollment | 128 participants |
| Start Date | 2025-06-03 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 128 participants in total. It began in 2025-06-03 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. Part B will be a randomized, open-label, 2-way crossover investigation to assess the effect of food on a single dose TVB-3567 administered orally in healthy participants. Parts C and D will be randomized, double-blind, placebo-controlled investigations of multiple ascending doses (MAD) to assess the safety, tolerability, PK, and PD/biomarkers of TVB-3567 administered orally in healthy participants without and with moderate to severe acne, respectively.
Eligibility Criteria
Inclusion Criteria: Healthy Participants (Parts A, B and C) 1. Healthy, adult, male or female 18-55 years of age 2. Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 3. Medically healthy with no clinically significant medical history 4. 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) Participants must meet all of the above criteria, as well as the following inclusion criteria to be eligible for participation in the study: 1. BMI ≥18.0 and ≤37.0 kg/m2. 2. Must be diagnosed with moderate to severe acne vulgaris Exclusion Criteria: Healthy Participants (Parts A, B and C) 1. History or presence of clinically significant medical or psychiatric condition or disease 2. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds including over the counter acne products. 3. Has a clinically significant ophthalmic examination finding 4. Female participant of childbearing potential 5. Unable to refrain from or anticipates the use of: * 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: 1. Unable to refrain from or anticipates the use of: * Any previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all trans retinoic acid. * Photoelectric therapy, dermabrasion, or chemical peeling * Intra-articular and systemic corticosteroid therapy 2. Significant skin diseases
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06989840 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Acne. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06989840 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06989840 currently recruiting?
Yes, NCT06989840 is actively recruiting participants. Contact the research team at SB3567-CLIN-001@sagimet.com for enrollment information.
Where is the NCT06989840 trial being conducted?
This trial is being conducted at Tempe, United States, Melbourne, Australia.
Who is sponsoring the NCT06989840 clinical trial?
NCT06989840 is sponsored by Sagimet Biosciences Inc.. The trial plans to enroll 128 participants.