Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema

• Status: Recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluates the efficacy of orally administered PHA-022121 for the acute treatment of attacks in patients with hereditary angioedema (HAE). Eligible subjects are randomized to one of three single doses of PHA-022121 and placebo. The study will compare symptom relief (skin pain, skin swelling, abdominal pain) during HAE attacks and safety of each dose of PHA-022121 with placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pharvaris Netherlands B.V.

Criteria

Key Inclusion Criteria:

1. Signed and dated informed consent form

2. Diagnosis of HAE type I or II

3. Documented history of HAE attacks: at least three in the last 4 months, or at least two in the last 2 months prior to screening

4. Reliable access and experience to use standard of care acute attack medications

Key Exclusion Criteria:

1. Pregnancy or breast-feeding

2. Clinically significant abnormal electrocardiogram

3. Any other systemic disease or significant disease or disorder that would interfere with the patient's safety or ability to participate in the study

4. Use of C1-esterase inhibitor, oral kallikrein inhibitors, attenuated androgens, anti-fibrinolytics, or monoclonal HAE therapy within a defined period prior to enrollment

5. Positive serology for HIV or active infection with hepatitis B virus or hepatitis C virus

6. Abnormal hepatic function

7. Abnormal renal function

8. History of alcohol or drug abuse within defined period, or current evidence of substance dependence or abuse

9. History of documented severe hypersensitivity to any medicinal product

10. Participation in any other investigational drug study within defined period