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ORKA-002-211 A Phase I Study to Evaluate ORKA-002 in Healthy Volunteers Following A Single Dose

StatusCompleted
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial completed Primary completion date changed from estimate of Jan 2027 to Aug 20, 2026 · Eligibility criteria expanded, about 12 words · Secondary endpoints: details revised at 1 of 4 entries Show 3 more changesShow less
    • Primary completion date changed from estimate of Jan 2027 to Aug 20, 2026
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 1 of 4 entries
  2. Trial status: Recruiting to Active, Not Recruiting Site details revisedv4 Show 1 more changeShow less
    • Site details revised
  3. Start date changed from estimate of Jul 2025 to May 19, 2025v3
  4. Trial status: Not Yet Recruiting to Recruiting Site details revisedv2 Show 1 more changeShow less
    • Site details revised
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a Phase 1, first-in-human study to evaluate the safety, tolerability, and pharmacokinetics of ORKA-002 in healthy participants.
Trial Details
NCT Number NCT06944379
Lead Sponsor Oruka Therapeutics, Inc.
Conditions Healthy Volunteers
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov