NCT07049328

HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata

A Phase 1 Study of HCW9302, an IL-2 Fusion Protein, for Alopecia Areata

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: HCW Biologics · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, open-label, multi-center, competitive enrollment, and dose-escalation study of HCW9302 in subjects with Alopecia Areata (AA)

Detailed 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 will be considered.

Conditions

• Alopecia Areata(AA)

Interventions

Type	Name	Description
DRUG	HCW9302, an IL-2 fusion protein	Injection

Timeline

• Start date: 2025-08-16
• Primary completion: 2026-07-16
• Completion: 2026-12-15
• First posted: 2025-07-03
• Last updated: 2025-10-20

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study