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

Study acronym: PNH
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Site details revised at 3 of 4 sitesv8
  2. Primary completion pushed from Mar 30, 2026 to Mar 31, 2028 Trial status changed: Active, Not Recruiting → Recruiting · Completion pushed from Sep 30, 2026 to Jul 31, 2028 · Site details revised at 4 of 4 sitesv7 Show 3 more changesShow less
    • Trial status changed: Active, Not Recruiting → Recruiting
    • Completion pushed from Sep 30, 2026 to Jul 31, 2028
    • Site details revised at 4 of 4 sites
  3. Re-verified, no change to tracked fieldsv6
  4. Trial status: Recruiting to Active, Not Recruiting Site details revised at 4 of 4 sitesv5 Show 1 more changeShow less
    • Site details revised at 4 of 4 sites
  5. Phase: Phase 1 to Phase 1/2 Primary completion date: Nov 30, 2024 to Mar 30, 2026 · Start date: Jul 3, 2023 to Aug 7, 2023 · Primary endpoints: 4 to 2 · 8 morev4 Show 11 more changesShow less
    • Primary completion date: Nov 30, 2024 to Mar 30, 2026
    • Start date: Jul 3, 2023 to Aug 7, 2023
    • Primary endpoints: 4 to 2
    • Enrollment target: 53 to 50
    • Study sites: 3 to 4
    • Completion date: Jun 30, 2025 to Sep 30, 2026
    • Eligibility criteria shortened, about 212 words
    • Secondary endpoints: 22 to 5
    • Study description expanded, about 7 words
    • Collaborators: 1 to 2
    • Study title expanded, about 1 word

    See this version in full on ClinicalTrials.gov ↗

Show 2 earlier versionsHide 2 earlier versions
  1. Study sites: 1 to 3 Eligibility criteria expanded, about 196 wordsv3 Show 1 more changeShow less
    • Eligibility criteria expanded, about 196 words

    See this version in full on ClinicalTrials.gov ↗

  2. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Jun 30, 2023 to Jul 3, 2023 · Site details revisedv2 Show 2 more changesShow less
    • Start date changed from estimate of Jun 30, 2023 to Jul 3, 2023
    • Site details revised
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov