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A Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Two Participants Groups (Part A: Healthy Participants, and Part B: Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency)

StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated July 2, 2026 (before its estimated September 28, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Site details revised at 2 of 10 sitesv18
  2. Enrollment target: 36 to 31
    • Primary and study completion dates: Jul 1, 2026 to Sep 28, 2026
    v17
  3. Primary and study completion dates: Apr 27, 2026 to Jul 1, 2026v16
  4. Eligibility criteria expanded, about 204 words
    • Study description expanded, about 6 words
    • Site details revised at 2 of 10 sites
    • Study title expanded, about 4 words
    v15
  5. Study sites: 8 to 10v14
Show 12 earlier versionsHide 12 earlier versions
  1. Re-verified, no change to tracked fieldsv13
  2. Start date: Apr 15, 2024 to May 10, 2024v12
  3. Study sites: 7 to 8v11
  4. Study sites: 6 to 7v10
  5. Enrollment target: 39 to 36
    • Study sites: 5 to 6
    v9
  6. Trial status: Active, Not Recruiting to Recruiting
    • Enrollment target: 45 to 39
    • Site details revised at 5 of 5 sites
    v8
  7. Secondary endpoints: 13 to 12
    • Eligibility criteria expanded, about 5 words
    • Study description shortened, about 1 word
    v7
  8. Trial status: Recruiting to Active, Not Recruiting
    • Primary and study completion dates: May 2, 2026 to Apr 27, 2026
    • Site details revised at 5 of 5 sites
    v6
  9. Study sites: 4 to 5v5
  10. Study sites: 1 to 4
    • Primary and study completion dates: Mar 30, 2026 to May 2, 2026
    v4
  11. Primary and study completion dates: Sep 27, 2025 to Mar 30, 2026v3
  12. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 8, 2024 to Apr 15, 2024
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamic (PD) of SR604 in healthy participants (Part A) and to evaluate the safety, tolerability, PK, PD, and efficacy of SR604 in participants with Hemophilia A or Hemophilia B, or Factor VII (FVII) deficiency, with or without inhibitors (Part B).
Trial Details
NCT Number NCT06349473
Lead Sponsor Equilibra Bioscience LLC
Conditions
(from sponsor)		 Healthy Participants, Hemophilia A, Hemophilia B, Factor VII Deficiency
Related terms Factor VII Deficiency, Hemophilia A, Hemophilia B
Enrollment 31 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov