SR604 / Equilibra Biosci - LARVOL DELTA

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 (ChiCTR) - P1/2 | N=76 | Completed | Sponsor: Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences; Institute of Hematology & Blood Diseases Hospital, Chi

New P1/2 trial • Hematological Disorders • Hemophilia • Hemophilia A • Rare Diseases

Shanghai RAAS: Announcement on the entry of "SR604 Injection" into Phase IIb clinical trial research [Google translation] (Sina Corp) - "Shanghai RAAS Blood Products Co., Ltd...recently announced the registration information of Phase IIb clinical trial on the National Drug Administration's drug clinical trial registration and information disclosure platform. The relevant information is now announced as follows: Phase IIb clinical trial related information...Drug name: SR604 injection...Trial registration number: CTR20241608...Test plan number: LS-SR604-Ⅰ01...Part A: Dose escalation Phase I trial (single-dose phase): To evaluate the safety, tolerability, immunogenicity and pharmacokinetic characteristics of SR604 after a single dose in patients with hemophilia A/B."

Trial status • Hemophilia A • Hemophilia B

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) (clinicaltrials.gov) - P1 | N=39 | Recruiting | Sponsor: Equilibra Bioscience LLC | Active, not recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

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) (clinicaltrials.gov) - P1 | N=45 | Active, not recruiting | Sponsor: Equilibra Bioscience LLC | Recruiting ➔ Active, not recruiting

Enrollment closed • Hematological Disorders • Hemophilia • Hemophilia A • Hemophilia B • Rare Diseases

Safety and efficacy of anti-human activated protein C antibody SR604 for prophylaxis of congenital factor deficiencies (ISTH 2024) - "SR604 effectively blocked the anticoagulation activities of APC in various human coagulation factor-deficient plasma in vitro with affinities approximately 60 times greater than that of HAPC1573. SR604 exhibited prophylactic and therapeutic efficacy in the tail bleeding and knee injury models of hemophilia A and B mice expressing human APC (humanized hemophilia mice). SR604 did not interfere with the cyto-protection and endothelial barrier function of APC nor have obvious toxicity effects in humanized hemophilia mice."

Clinical • Hematological Disorders • Hemophilia • Inflammation • Rare Diseases

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) (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Equilibra Bioscience LLC | Trial completion date: Sep 2025 ➔ Mar 2026 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Trial completion date • Trial primary completion date • Hematological Disorders • Hemophilia • Rare Diseases

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) (clinicaltrials.gov) - P1 | N=45 | Recruiting | Sponsor: Equilibra Bioscience LLC | Not yet recruiting ➔ Recruiting

Enrollment open • Hematological Disorders • Hemophilia • Rare Diseases