Evaluating the safety and effects of TVB-3567 in healthy individuals and those with acne

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a four-part clinical trial designed to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of the drug TVB-3567. The first part involves a randomized, double-blind, placebo-controlled approach to evaluate single ascending doses in healthy participants. Subsequent parts will investigate the effects of food on the drug and multiple ascending doses in both healthy participants and those with moderate to severe acne. The study aims to gather comprehensive data on the drug's effects and safety profile.

Why it matters

Who can join: the full rules

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 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.
2. Significant skin diseases

Where it's running

• Emeritus Research
  Botany, New South Wales, Australia Recruiting
• Emeritus Research
  Camberwell, Victoria, Australia Recruiting
• Fremantle Dermatology
  Fremantle, Western Australia, Australia Recruiting
• Celerion, Inc.
  Tempe, Arizona, United States Completed
• The Skin Hospital
  Darlinghurst, New South Wales, Australia Not yet recruiting
• Nucleus Network
  Melbourne, Victoria, Australia Completed

Study contacts

• Study coordinator: Study Director
• Email: SB3567-CLIN-001@sagimet.com
• Phone: (650) 561-8600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.