Evaluating the safety and effects of TVB-3567 in healthy individuals and those with acne
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 study is testing a new drug called TVB-3567 to see how safe it is and how it works in healthy people and those with acne.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 55 Years |
| Sex | All |
| Sponsor | Sagimet Biosciences Inc. Industry-sponsored |
| Locations | 2 sites (Tempe, Arizona and 1 other locations) |
| Trial ID | NCT06989840 on ClinicalTrials.gov |
What this trial studies
This is a four-part clinical trial designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the drug TVB-3567. The first part involves a randomized, double-blind, placebo-controlled approach to evaluate single ascending doses in healthy participants. Subsequent parts will investigate the effects of food on the drug and multiple ascending doses in both healthy participants and those with moderate to severe acne. The study aims to gather comprehensive data on the drug's effects and safety profile.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18-55 and individuals with moderate to severe acne who meet specific health criteria.
Not a fit: Patients with significant medical or psychiatric conditions or those with a history of hypersensitivity to related compounds may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for individuals suffering from acne.
How similar studies have performed: While this study explores a novel approach, similar studies have shown promise in evaluating new treatments for acne.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tempe, Arizona and 1 other locations
- Celerion, Inc. — Tempe, Arizona, United States (Completed)
- Nucleus Network — Melbourne, Victoria, Australia (Recruiting)
Study contacts
- Study coordinator: Study Director
- Email: SB3567-CLIN-001@sagimet.com
- Phone: (650) 561-8600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.