Clinical Trial

Safety, Tolerability, PK and PD of ADX-038 in Healthy Participants and Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients

Study acronym: PNH
Recruiting Phase 1/2
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Summary
The first-in-human Phase 1/Phase 2a study described herein will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-038 in both healthy participants (HP) and in patients with paroxysmal nocturnal hemoglobinuria (PNH).
Protocol Amendment History 3 changes
critical Trial status changed: Active, Not Recruiting → Recruiting 2026-04-23
notable Primary completion pushed: 2026-03-30 -> 2028-03-31 2026-04-23
minor Completion pushed: 2026-09-30 -> 2028-07-31 2026-04-23
Trial Details
NCT Number NCT05876312
Lead Sponsor ADARx Pharmaceuticals, Inc.
Collaborators: ADARx Australia Pty Ltd, Novotech (Australia) Pty Limited
Conditions Paroxysmal Nocturnal Hemoglobinuria (PNH)
Enrollment 50 participants
Start Date 2023-08-07
Primary Completion 2028-03-31 (estimated)
Study Completion 2028-07-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-16