Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne

Launched by SAGIMET BIOSCIENCES INC. · May 16, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called TVB-3567 to see how safe it is and how it works in healthy adults, both with and without acne. The study is divided into four parts. The first part will give participants different doses of the medication, some of which will be a placebo (a pill with no active drug), to see how well the body tolerates it. The second part will test how eating food affects the medication’s effectiveness. The last two parts will give multiple doses of the medication to both healthy participants and those diagnosed with moderate to severe acne to further check safety and how the body responds.

To be eligible for this study, participants need to be healthy adults aged 18 to 55 with a specific body mass index (BMI). Those with acne need to have moderate to severe acne but still meet the health criteria. Participants can expect to be monitored closely during the study, including evaluations of their health and responses to the medication. It's important to note that certain medical conditions and previous treatments may exclude someone from participating, so potential volunteers should carefully review the eligibility criteria. Overall, this trial is a crucial step in understanding how TVB-3567 could help manage acne.

Gender

ALL

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