A Phase 3 Extension Study of siRNA Targeting of Prekallikrein With ADX-324 in Participants With Hereditary Angioedema
ADARx Pharmaceuticals, Inc.
Summary
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
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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) Exclusion Criteria: * A negative reaction to study drug in ADX-324-301
Interventions
- DrugADX-324 Dose Level 1
siRNA duplex oligonucleotide
- DrugADX-324 Dose Level 2
siRNA duplex oligonucleotide
Locations (48)
- ADARx Clinical SiteLitchfield Park, Arizona
- ADARx Clinical SiteLittle Rock, Arkansas
- ADARx Clinical SiteSan Diego, California
- ADARx Clinical SiteWalnut Creek, California
- ADARx Clinical SiteOrlando, Florida
- ADARx Clinical SiteChevy Chase, Maryland