Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:46 AM
Ignite Modification Date:
2025-12-24 @ 11:46 AM
NCT ID:
NCT05691361
Brief 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).
Detailed 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:
NCT05691361
Study Brief:
Protocol Section:
NCT05691361