Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
Recruiting now · Phase 1 · Has a placebo group
Conditions studied: Acne
In brief
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.
Key facts
- Study ID
- NCT06989840
- Run by
- Sagimet Biosciences Inc.
- People needed
- 128
- Starts
- 2025-06-03
- Expected to finish
- 2027-01-01
- Last updated by the study team
- 2026-06-09
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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)
- 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
You may not qualify if…
- 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:
- 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 previous tretinoin treatments, including tazarotene, adapalene, isotretinoin, and all trans retinoic acid.
- Photoelectric therapy, dermabrasion, or chemical peeling
- Intra-articular and systemic corticosteroid therapy
- Significant skin diseases
Where it is running
- Nucleus Network — Melbourne, Victoria, Australia (enrolling)
- Celerion, Inc. — Tempe, Arizona, United States
Full record on ClinicalTrials.gov
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