A Pilot, Safety and Clinical Activity, Phase 1b Study of DR-01 in Adults With Alopecia Areata or Vitiligo
Dren Bio
Summary
This is a multi-center, parallel-group, open-label, randomized, Phase 1b study to explore the safety, clinical activity, pharmacokinetics and pharmacodynamics of DR-01 in adults with Alopecia Areata or Vitiligo.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
General Inclusion Criteria 1. Subjects aged ≥ 18 with the ability to understand and comply with protocol-required study procedures, and voluntarily sign a written informed consent document. 2. Women of childbearing potential (postmenarcheal, has an intact uterus and at least 1 ovary, and is \< 1 year postmenopausal) must agree to use a highly effective method of contraception (as specified in Section 13.1.1 or as permitted by regional regulatory authorities) from enrollment through at least 20 weeks after last dose of DR-01. 3. Male subjects must agree to use acceptable effective method(s) of…
Interventions
- DrugDR-01
DR-01 will be administered via IV infusion.
Locations (20)
- Dren Investigational SiteNorthridge, California
- Dren Investigational SiteMiami, Florida
- Dren Investigational SiteEvans, Georgia
- Dren Investigational SiteMeridian, Idaho
- Dren Investigational SiteIndianapolis, Indiana
- Dren Investigational SiteWest Lafayette, Indiana