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

Sagimet Biosciences

Status and phase: Enrolling; Phase 1

Conditions: Acne

Treatments: Drug: Placebo; Drug: TVB-3567

Study type: Interventional

Funder types: Industry

Identifiers

NCT06989840

SB3567-CLIN-001

Details and patient eligibility

About

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.

Enrollment: 128 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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128 participants in 4 patient groups

Part A (SAD in Healthy Participants)

Experimental group

Treatment:

Drug: TVB-3567

Drug: Placebo

Part B (Food Effect)

Experimental group

Treatment:

Drug: TVB-3567

Part C (MAD in Healthy Participants)

Experimental group

Treatment:

Drug: TVB-3567

Drug: Placebo

Part D (MAD in Acne Participants)

Experimental group

Treatment:

Drug: TVB-3567

Drug: Placebo