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HCW9302, an IL-2 fusion protein

Phase 1

Alopecia Areata(AA) | Small molecule | Dermatology |HCW Biologics Inc.|Last Updated: Aug 24, 2026

Target and mechanism

Molecular targetIL-2
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

HCW9302, an IL-2 fusion protein · 1 trial · 1 indication

Phase 1 1
NCT07049328HCW9302 (Interleukin-2 Fusion Protein) for Alopecia AreataAlopecia Areata(AA)
RECRUITING30 Analytics
PHASE1RECRUITING
HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata
Alopecia Areata(AA)Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment-Emergent Adverse Events (TEAEs) in Subjects Receiving HCW9302 Monotherapy
9 Weeks

Evaluate the safety profile of HCW9302 monotherapy in subjects with Alopecia Areata (AA), based on the incidence, type, and severity of adverse events (AEs) classified according to MedDRA.

Designate the recommended Phase 2 dose level (RP2D) for Phase 2 study of HCW9302 in subjects with AA
9 Weeks

Secondary Endpoints

Determine the percent change from baseline of Severity of Alopecia Tool (SALT) score (0-100) at Day 29 and Week 9 in AA subjects receiving HCW9302
9 Weeks
Determine the change from baseline of Alopecia Areata-Investigator Global Assessment (AA-IGA) score at Day 29 and Week 9 in AA subjects receiving HCW9302
9 Weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Study of HCW9302, an IL-2 fusion protein, for alopecia areataEXPERIMENTALSingle dose subcutaneous injection of HCW9302.

Interventions

NameTypeDescription
HCW9302, an IL-2 fusion proteinDRUGInjection
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

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 d...

Countries:United States
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Recent Changes (Last 90 Days)

MEDIUMAug 24, 2026NCT07049328primaryCompletionDate: changed
MEDIUMAug 24, 2026NCT07049328primaryCompletionDate: changed

Frequently asked questions about HCW9302, an IL-2 fusion protein

What is HCW9302 used for?

HCW9302 is an investigational IL-2 fusion protein being developed for the treatment of alopecia areata (AA), a dermatologic condition. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

What does HCW9302 target?

HCW9302 targets IL-2, a cytokine involved in immune regulation. As an IL-2 fusion protein, it is designed to modulate immune responses relevant to alopecia areata. The drug is being studied for its potential therapeutic effect in this condition.

Who makes HCW9302?

HCW9302 is being developed by HCW Biologics Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the safety and efficacy of this investigational drug for alopecia areata.

What phase is HCW9302 in?

HCW9302 is in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety and tolerability.

What clinical trials is HCW9302 in?

HCW9302 is being studied in a Phase 1 clinical trial with the identifier NCT07049328. This trial, titled 'HCW9302 (Interleukin-2 Fusion Protein) for Alopecia Areata,' is recruiting 30 participants in the United States. The study is open to adults aged 18 years and older.