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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-19

Study Completion Date

2026-01-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A (SAD in Healthy Participants)

Group Type EXPERIMENTAL

TVB-3567

Intervention Type DRUG

Orally administered capsule

Placebo

Intervention Type DRUG

Orally administered capsule

Part B (Food Effect)

Group Type EXPERIMENTAL

TVB-3567

Intervention Type DRUG

Orally administered capsule

Part C (MAD in Healthy Participants)

Group Type EXPERIMENTAL

TVB-3567

Intervention Type DRUG

Orally administered capsule

Placebo

Intervention Type DRUG

Orally administered capsule

Part D (MAD in Acne Participants)

Group Type EXPERIMENTAL

TVB-3567

Intervention Type DRUG

Orally administered capsule

Placebo

Intervention Type DRUG

Orally administered capsule

Interventions

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TVB-3567

Orally administered capsule

Intervention Type DRUG

Placebo

Orally administered capsule

Intervention Type DRUG

Eligibility Criteria

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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)

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)

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes