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Purpose

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.

Conditions

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
ADX-324 Dose Level 1
  • Drug: ADX-324 Dose Level 1
    siRNA duplex oligonucleotide
Experimental
ADX-324 Dose Level 2
  • Drug: ADX-324 Dose Level 2
    siRNA duplex oligonucleotide

Recruiting Locations

ADARx Clinical Site
Las Vegas, Nevada 89128

More Details

Status
Recruiting
Sponsor
ADARx Pharmaceuticals, Inc.

Study Contact

Lupe Gallegos
877-232-7974
info@adarx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.