Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: TVB-3567, Placebo.
- Who it may be relevant to
- Registry conditions: Acne. Basic parameters: 18 years — 55 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug TVB-3567
Orally administered capsule - Drug Placebo
Orally administered capsule
Primary outcome measures
- Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs) [Time frame: Baseline to 7 to 8 days after dosing]
- Part B - Plasma AUC0-t in fasted and fed conditions [Time frame: Baseline to Day 4]
- Part B - Plasma AUC0-inf in fasted and fed conditions [Time frame: Baseline to Day 4]
- Part B - Plasma Cmax in fasted and fed conditions [Time frame: Baseline to Day 4]
- Part B - Incidence of adverse events (AEs) and serious adverse events (SAEs) under fasted and fed conditions [Time frame: Baseline to 7 to 8 days after dosing]
- Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs) [Time frame: Baseline to 13 to 15 days after the last dose]
- Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs) [Time frame: Baseline to 13 to 15 days after the last dose]
Eligibility criteria
Inclusion criteria
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
Exclusion criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Celerion, Inc. — Tempe
Australia · 1 center
- Nucleus Network — Melbourne
Identifiers
NCT: NCT06989840 · SB3567-CLIN-001