Acne study: TVB-3567
Official title Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
ClinicalTrials.gov ID: NCT06989840
What this study is testing
What is TVB-3567?
TVB-3567 is an investigational oral capsule being studied as a potential treatment for acne.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will look at how safe the drug is, how well it is tolerated, and how it moves through the body. It will also measure changes in certain body markers that show the drug’s effect.
- Who it's for
- Healthy adults, some with moderate to severe acne and some without acne, who can take oral medication.
- What's involved
- Participants will receive the drug or a placebo in a series of doses. They will have blood tests, safety checks, and visits to see how the drug works and if food changes its effect.
- Time commitment
- The study lasts about 4 to 6 weeks, with several clinic visits for dosing, blood draws, and safety monitoring.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join if
- 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
- BMI ≥18.0 and ≤37.0 kg/m2.
You likely can't join if
- 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
- Any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements
See the full eligibility 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
- BMI ≥18.0 and ≤37.0 kg/m2.
- Must be diagnosed with moderate to severe acne vulgaris
- 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
- 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.
- Any topical prescription or non-prescription anti-acne cleansers or treatments on the face, beginning 14 days prior to the first dosing.
- Tretinoins, including tazarotene, adapalene, trifarotene, tretinoin, photodynamic therapy, dermabrasion, or chemical peeling (on the face) beginning 4 weeks prior to the first dosing.
- Oral retinoid (isotretinoin) therapy beginning 6 months prior to the first dosing.
- Significant skin diseases
The study team makes the final eligibility decision.
Where it is enrolling
- Botany, New South Wales, Australia
- Camberwell, Victoria, Australia
- Fremantle, Western Australia, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Botany, New South Wales, Australia; Camberwell, Victoria, Australia; Fremantle, Western Australia, Australia. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.