Status: Recruiting

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)

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).

Participants needed: 31

Trial details

Phase: Phase 1Age: 18-60Biological sex: AllType: InterventionalSponsor: Equilibra Bioscience LLCUpdated: Jul 2, 2026Locations: 10

Eligibility criteria

Male participants aged 18 to 55 years, inclusive. [+13]

Participant has clinically significant history or evidence of cardiovascular, re... [+33]

Status: Recruiting

An Open-label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetic/Pharmacodynamic (PK/PD) Characteristics of SR604 Injection in Patients With Hemophilia A/B and Congenital Factor VII Deficiency

The purpose of this study is to evaluate the safety, tolerability, immunogenicity , PK, and PD of a single dose of SR604 in participants with Hemophilia A or Hemophilia B, with or without inhibitors （Part A）and to evaluate the safety, PK, PD, and efficacy of multiple doses of SR604 in participants with Hemophilia A or Hemophilia B, or Factor VII (FVII) deficiency, with or without inhibitors (Part B and Part C).

Participants needed: 76

Trial details

Phase: Phase 1, Phase 2Age: 18-65Biological sex: AllType: InterventionalSponsor: Shanghai RAAS Blood Products Co., Ltd.Updated: Jun 12, 2026Locations: 9

Eligibility criteria

Age ≥18 years and ≤65 years at the time of signing informed consent, regardless... [+7]

Subjects with a known history of hypersensitivity to the investigational medicin... [+23]