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Clinical Trial Summary

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).


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05691361
Study type Interventional
Source ADARx Pharmaceuticals, Inc.
Contact CMAX Reception
Phone +610870887900
Email Jane.kelly@cmax.com.au
Status Recruiting
Phase Phase 1
Start date December 14, 2022
Completion date November 26, 2024

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