A Healthy Volunteer Study Evaluating the Tolerability and Pharmacokinetics of PRN473 Topical
- Conditions
- Immune-mediated dermatological diseasesInflammatory and Immune System - Autoimmune diseasesSkin - Dermatological conditions
- Registration Number
- ACTRN12620000264987
- Lead Sponsor
- Principia Biopharma Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 60
1. Healthy adult men or women who are surgically sterile or postmenopausal or using acceptable, effective contraceptive measures, 18-65 years old and able to provide written consent.
2. Must have clinical laboratory values within normal.
3. Must have appropriate skin characteristics at the application site
1. Women who are pregnant or lactating
2. Positive testing for human immunodeficiency virus , hepatitis B surface antigen, or hepatitis C antibodies
3. Clinically significant medical history of chronic or acute disease or infection
4. History of alcoholism, drug abuse or significant tobacco use
5. Use of a a tanning salon 2 weeks prior to study start
6. Blood donation or significant blood loss of more than 400 milliliter within 60 days prior to Screening
7. Participation in another clinical trial of a drug or device whereby the last investigational drug or device administration is within 60 days prior to the first study drug administration or 5 half-lives, whichever is longer
8. Previous exposure to PRN473 oral formulation
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method