A Phase 1 Study of HCW9302, an IL-2 Fusion Protein, for Alopecia Areata
HCW Biologics
Summary
This is a Phase 1, open-label, multi-center, competitive enrollment, and dose-escalation study of HCW9302 in subjects with Alopecia Areata (AA)
Description
The study involves dose escalation to determine the toxicity profile of HCW9302 and to designate a dose level for the Phase 2 expansion phase (RP2D). Up to five HCW9302 dose levels will be evaluated. A step-down dose level (level -1) will be provided in the event that unacceptable toxicity is encountered at the planned initial dose level. In the first stage of the study, HCW9302 will be administered subcutaneously as a single dose. Depending on the results of the single ascending dose stage, a multidose study of HCW9302 administered subcutaneously every 28 days for 4 consecutive treatments wi…
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. Adult women who are 18 to 70 years of age, or adult males who are 18 to 60 years of age at the time of informed consent. 2. Clinical diagnosis of Alopecia Areata (AA) (including ophiasis, totalis or universalis forms) at Screening. 3. Negative serum pregnancy test within 14 days of treatment start if female and of childbearing potential (non-childbearing is defined as greater than one year postmenopausal or surgically sterilized). 4. Female subjects of childbearing potential must adhere to using a highly effective medically accepted method of birth control (defined as t…
Interventions
- DrugHCW9302, an IL-2 fusion protein
Injection
Locations (2)
- James A. Haley Veterans' HospitalTampa, Florida
- The Ohio State University Wexner Medical CenterColumbus, Ohio