A Phase 1 Study of HCW9302, an IL-2 Fusion Protein, for Alopecia Areata
This is a Phase 1, open-label, multi-center, competitive enrollment, and dose-escalation study of HCW9302 in subjects with Alopecia Areata (AA)
• 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.
• Clinical diagnosis of Alopecia Areata (AA) (including ophiasis, totalis or universalis forms) at Screening.
• 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).
• Female subjects of childbearing potential must adhere to using a highly effective medically accepted method of birth control (defined as those with failure less than 1%; see Appendix 2) prior to screening and agree to continue its use for at least 28 days after the last dose of HCW9302 or be surgically sterilized (e.g., hysterectomy or tubal ligation) and males must agree to use a barrier method of birth control and agree to continue its use for at least 28 days after the last dose of HCW9302.
• Laboratory tests performed within 28 days of treatment start:
‣ Absolute neutrophil count (AGC/ANC) ≥ 1,500/μL (≥1.5 × 109/L)
⁃ Platelets ≥ 100,000/μL (≥ 100 × 109/L)
⁃ Hemoglobin ≥ 10 g/dL (\>100g/L)
⁃ Calculated glomerular filtration rate (GFR)\* \>40 mL/min OR serum creatinine ≤ 1.5 × ULN
⁃ Total bilirubin ≤ 2.0 × ULN or ≤ 3.0 × ULN for subjects with Gilbert's syndrome
⁃ AST, ALT, ALP ≤ 2.0 × ULN
• Able and willing to comply with requested study visits and procedures.
• Able and willing to provide written informed consent and HIPAA authorization