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A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants.

StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 54 days later Sep 23, 2026 → Nov 16, 2026
See other at-risk trials from AstraZeneca

Record History

  1. Enrollment closed, study ongoing Primary and study completion pushed from Sep 23, 2026 to Nov 16, 2026 · Final enrollment: 72 participants (planned 136) · Eligibility criteria expanded, about 7 words · 3 more Show 6 more changesShow less
    • Primary and study completion pushed from Sep 23, 2026 to Nov 16, 2026
    • Final enrollment: 72 participants (planned 136)
    • Eligibility criteria expanded, about 7 words
    • Secondary endpoints: details revised at 3 of 5 entries
    • Study description expanded, about 6 words
    • Site details revised
  2. 2 versions Re-verified since Apr 24, 2026, no change to tracked fieldsv9-v10
  3. Study description revised Study arms: 12 to 13v8 Show 1 more changeShow less
    • Study arms: 12 to 13

    See this version in full on ClinicalTrials.gov ↗

  4. Primary and study completion dates: Oct 12, 2026 to Sep 23, 2026v7
  5. 4 versions Re-verified since Aug 14, 2025, no change to tracked fieldsv3-v6
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Secondary endpoints revised (5)v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Secondary endpoints revised (5)

    See this version in full on ClinicalTrials.gov ↗

  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
AstraZeneca
727 trials monitored
See 61 trials at risk
The purpose of the study is to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of AZD1613 in healthy participants, including Japanese and Chinese descent.
Trial Details
NCT Number NCT06995820
Lead Sponsor AstraZeneca
Collaborators: Parexel
Conditions Healthy
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov