None listed
Conditions
Brief summary
The purpose of this research study is to assess the safety and tolerability of PRN473 Topical as well as the pharmacokinetics (PK - how your body absorbs medications). We are doing this study in healthy men and women to find out: • Does the drug have any side-effects and is it well tolerated when given topically as a single dose and in multiple doses? • How much of the drug when given topically gets into the blood stream, and how long does the body take to get rid of it? This study will compare PRN473 Topical with placebo. A placebo has no active drug in it. One group of participants will receive PRN473 Topical and another group will receive the topical placebo. The effects seen in participants receiving the study drug will be compared to the effects seen in participants who receive the placebo. This study will look at how participants react to, and how the human body uses PRN473 Topical at different dose levels. In total there are planned to be 2 parts to the study. Part A will look at the effects of a single topical dose of the study drug and Part B will look at the effects of multiple topical doses of the study drug
Interventions
This study consists of 2 parts (Part A and Part B).
Participants in each cohort of Part A will receive a single ascending dose of either 14g of 0.5%, 14g of 2%, 14g of 5%, 3.75g of 5% or 7.5g of 5% PRN473 Topical or placebo. They will stay overnight in the clinic until completion of the 24 hour post dose assessment and then be discharged. The participant will then return on Day 4 for end of study assessments.
Part B consists of 1 cohort in which the participants will receive repeat doses of ei
This study consists of 2 parts (Part A and Part B). Participants in each cohort of Part A will receive a single ascending dose of either 14g of 0.5%, 14g of 2%, 14g of 5%, 3.75g of 5% or 7.5g of 5% PRN473 Topical or placebo. They will stay overnight in the clinic until completion of the 24 hour post dose assessment and then be discharged. The participant will then return on Day 4 for end of study assessments. Part B consists of 1 cohort in which the participants will receive repeat doses of either 3.5 g of PRN473 5% Topical or placebo. Each participant will be dosed twice a day for 7 days. They will remain at the clinic for the 7 days of dosing and discharge on the 9th day . The participant will then return on Day 10 for end of study assessments. Each application of topical PRN473 will be up to 14g that will contain either 0.5% , 2%, or 5% of PRN473 . Topical PRN473 will be applied over a patch of skin on the back measuring about 1400cm2.
Sponsors
Principia Biopharma Inc.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
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
Outcome results
None listed