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

ConditionAcne
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorSagimet Biosciences Inc.

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Sequential

Treatments tested in this trial

  • TVB-3567

    Drug

    Orally administered capsule

  • Placebo

    Drug

    Orally administered capsule

Treatment groups

128 Participants
are divided into 4 treatment groups
Group A: Part A (SAD in Healthy Participants)Experimental treatment 2 interventions
Group B: Part B (Food Effect)Experimental treatment 1 intervention
Group C: Part C (MAD in Healthy Participants)Experimental treatment 2 interventions
Group D: Part D (MAD in Acne Participants)Experimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs)

Time frame
Baseline to 7 to 8 days after dosing
2

Part B - Plasma AUC0-t in fasted and fed conditions

Area under the concentration-time curve from time zero until the last observed concentration

Time frame
Baseline to Day 4
3

Part B - Plasma AUC0-inf in fasted and fed conditions

Area under the concentration-time curve from time zero to infinity

Time frame
Baseline to Day 4
4

Part B - Plasma Cmax in fasted and fed conditions

Maximum concentration measurement in plasma

Time frame
Baseline to Day 4

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sagimet Biosciences Inc.

Lead sponsor

Source ClinicalTrials.gov
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