About this trial

Study ADX-324-302 is an extension study for participants who complete the Phase 3 ADX-324-301 trial. The extension study will provide information about the safety and efficacy of additional dosing of ADX-324 in participants with Type I and Type II hereditary angioedema (HAE). The study will also include pharmacodynamic (PD), pharmacokinetic (PK), and health-related quality of life (HRQoL) measurements.

Eligibility criteria

Qualifiers

Have a documented diagnosis of HAE (Type I or II)

Completed Study ADX-324-301

Have access to an acute therapy to treat HAE attacks (such as plasma derived or recombinant C1-INH concentrate or a BK2-receptor antagonist)

Disqualifiers

A negative reaction to study drug in ADX-324-301

Trial design

Treatments tested in this trial

  • ADX-324 Dose Level 1
  • ADX-324 Dose Level 2

Treatment groups

90 Participants
are divided into 2 treatment groups

Locations

48
Argentina
ADARx Clinical SiteC1425BEN, Capital FederalBuenos Aires, Argentina
ADARx Clinical SiteC1035AAT, Buenos AiresBuenos Aires F.D., Argentina
Australia
ADARx Clinical Site5000, AdelaideSouth Australia, Australia
Austria
ADARx Clinical Site1090, Vienna Austria

Sponsors and collaborators

ADARx Pharmaceuticals, Inc.

Lead sponsor