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Safety, Tolerability, PK, PD of ADX-324 in Healthy Volunteers and Hereditary Angioedema Patients

StatusActive, Not Recruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Re-verified, no change to tracked fieldsv10
  2. Primary and study completion dates: Dec 30, 2027 to Dec 31, 2027v9
  3. Re-verified, no change to tracked fieldsv8
  4. Primary completion date: Sep 30, 2025 to Dec 30, 2027 Trial status: Recruiting to Active, Not Recruiting · Completion date: Jan 31, 2026 to Dec 30, 2027 · Site details revisedv7 Show 3 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Completion date: Jan 31, 2026 to Dec 30, 2027
    • Site details revised
  5. Primary completion date changed from estimate of Jul 21, 2025 to Sep 30, 2025v6
Show 4 earlier versionsHide 4 earlier versions
  1. Phase: Phase 1 to Phase 1/2v5
  2. Primary completion date: Jan 2, 2025 to Jul 21, 2025 Completion date: Dec 26, 2025 to Jan 31, 2026 · Collaborators expanded, about 4 wordsv4 Show 2 more changesShow less
    • Completion date: Dec 26, 2025 to Jan 31, 2026
    • Collaborators expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  3. Primary completion date: Jan 2, 2024 to Jan 2, 2025 Completion date: Nov 26, 2024 to Dec 26, 2025v3 Show 1 more changeShow less
    • Completion date: Nov 26, 2024 to Dec 26, 2025
  4. Secondary endpoints: details revised at 20 of 20 entriesv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ADX-324 in healthy volunteers (HV) and in patients with Hereditary Angioedema (HAE).
Trial Details
NCT Number NCT05691361
Lead Sponsor ADARx Pharmaceuticals, Inc.
Collaborators: Avance Clinical Pty Ltd.
Conditions Hereditary Angioedema
Enrollment 53 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov