Clinical trial NCT06989840: Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Acne
Lead sponsor: Sagimet Biosciences Inc.
Sponsor class: INDUSTRY
First posted: 2025-05-25
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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

Primary outcomes:
measure: Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Baseline to 7 to 8 days after dosing
measure: Part B - Plasma AUC0-t in fasted and fed conditions
timeFrame: Baseline to Day 4
measure: Part B - Plasma AUC0-inf in fasted and fed conditions
timeFrame: Baseline to Day 4
measure: Part B - Plasma Cmax in fasted and fed conditions
timeFrame: Baseline to Day 4
measure: Part B - Incidence of adverse events (AEs) and serious adverse events (SAEs) under fasted and fed conditions
timeFrame: Baseline to 7 to 8 days after dosing
measure: Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Baseline to 13 to 15 days after the last dose
measure: Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs)
timeFrame: Baseline to 13 to 15 days after the last dose
Secondary outcomes:
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion, Inc.
state: Arizona
Study officials:
References: