Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
- Registration Number
- NCT06989840
- Lead Sponsor
- Sagimet Biosciences Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 128
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
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part A (SAD in Healthy Participants) TVB-3567 - Part A (SAD in Healthy Participants) Placebo - Part B (Food Effect) TVB-3567 - Part C (MAD in Healthy Participants) TVB-3567 - Part C (MAD in Healthy Participants) Placebo - Part D (MAD in Acne Participants) TVB-3567 - Part D (MAD in Acne Participants) Placebo -
- Primary Outcome Measures
Name Time Method Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs) Baseline to 7 to 8 days after dosing Part B - Plasma AUC0-t in fasted and fed conditions 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 Baseline to Day 4 Area under the concentration-time curve from time zero to infinity
Part B - Plasma Cmax in fasted and fed conditions 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 Baseline to 7 to 8 days after dosing Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs) Baseline to 13 to 15 days after the last dose Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs) Baseline to 13 to 15 days after the last dose
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Celerion, Inc.
🇺🇸Tempe, Arizona, United States
Celerion, Inc.🇺🇸Tempe, Arizona, United States