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)
NCT06349473 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 31
Last updated 2026-03-10
Summary
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).
Conditions
- Healthy Participants
- Hemophilia A
- Hemophilia B
- Factor VII Deficiency
Interventions
- DRUG
-
SR604
SR604 will be administered as SC injection.
- DRUG
-
Placebo will be administered as single SC injection.
Sponsors & Collaborators
-
Equilibra Bioscience LLC
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2024-05-10
- Primary Completion
- 2026-09-28
- Completion
- 2026-09-28
- FDA Drug
- Yes
Countries
- United States
- Canada
Study Locations
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