Hereditary Angioedema Clinical Trial
Official title:
A Phase 1, Randomized, Placebo-Controlled, Double Blind Single Ascending Dose Study in Healthy Volunteers and an Expansion Cohort in Patients With Hereditary Angioedema to Evaluate the Safety, Tolerability, PK and PD of ADX-324
The first-in-human Phase 1 study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-324 in healthy volunteers (HV) and in patients with Hereditary Angioedema (HAE).
The clinical study described in this protocol is a Phase 1, single-center study evaluating safety, tolerability, PK, and PD of ADX-324. The study consists of 2 parts: - Randomized, double-blind, placebo-controlled, parallel group, single ascending dose (SAD) in HV with up to 6 dose cohorts. For SAD cohorts and planned dosing; and, - Expansion cohort in participants with Hereditary Angioedema (HAE) at selected dose from Part A and will be open label. ;
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