New acne pill enters first human tests
NCT ID NCT06989840
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial tests an experimental oral drug called TVB-3567 in 128 healthy adults, some with acne. The main goal is to check safety and how the body processes the drug, not yet whether it works. Results will help decide if larger studies are warranted.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TVB-3567 (oral capsule)
- What this could lead to
- If safe and effective, this could lead to a new oral treatment for acne.
- What could go wrong
- This is a very early Phase 1 trial focused on safety and dosing, not on curing acne. It may fail to show benefit or have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 128 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2025
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Celerion, Inc.
COMPLETEDTempe, Arizona, 85283, United States
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Nucleus Network
RECRUITINGMelbourne, Victoria, 3004, Australia
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