A Phase II Exploratory Study of SR604 Injection Evaluating the Safety and Efficacy in the Treatment of Congenital Coagulation Factor VII Deficiency

NCT07711158 | Not Yet Recruiting Phase 2

• 1 other identifier: LS-SR604-VII-II01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, multicenter, exploratory Phase II clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic characteristics of SR604 Injection in patients with congenital coagulation Factor VII deficiency.

Conditions

Factor VII Deficiency

Outcome Measures

Primary Outcomes (1)

• Treated overall Annualized Bleeding Rate (ABR)

  Through 28 weeks of treatment.

Secondary Outcomes (8)

• Treated spontaneous annualized bleeding rate

  over 28 weeks of treatment

• Treated overall annualized joint bleeding rate

  over 28 weeks of treatment

• Overall annualized bleeding rate including treated and untreated bleeding events

  over 28 weeks of treatment,

• Annualized menorrhagia bleeding rate (menstruating females only)

  over 28 weeks of treatment

• Change in PBAC score (menstruating females only);

  From baseline over 28 weeks of treatment

Other Outcomes (8)

• Single-dose pharmacokinetic (PK) parameters:Time to Peak Plasma Concentration (Tmax)

  over 28 weeks of treatment

• Single-dose pharmacokinetic (PK) parameters:Peak Plasma Concentration (Cmax)

  over 28 weeks of treatment

• Single-dose pharmacokinetic (PK) parameters:Area Under the Concentration-Time Curve from Zero to Last Quantifiable Time Point (AUC0-t)

  over 28 weeks of treatment

Study Arms (1)

SR604：Multiple-dose exploratory efficacy trial consists of 2 cohorts

EXPERIMENTAL

Participants with FVII deficiency will receive SR604 dose 1/2 as multiple SC injections every 4-weeks

Drug: SR604

Interventions

SR604 DRUG

SR604 will be administered as SC injection.

SR604：Multiple-dose exploratory efficacy trial consists of 2 cohorts

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥12 years and ≤65 years at the time of signing the informed consent form; both genders eligible;
• Clinically diagnosed with congenital coagulation Factor VII deficiency, with historical or screening FVII activity \<10%, and ≥2 treated new-onset bleeding events within 3 months prior to enrollment;
• No active bleeding symptoms prior to first administration of SR604 Injection;
• The subject and/or legal representative and impartial witness have signed the informed consent form, indicating voluntary agreement to participate in this trial, to provide biological samples for testing as required by the protocol, and to comply with the planned study visits;
• Female subjects (post-menarche) must have a negative serum pregnancy test (HCG) during the screening period; subjects with childbearing potential (females post-menarche or males post-spermarche) must agree to use highly effective contraceptive measures throughout the study period.

You may not qualify if:

• Known history of hypersensitivity to the study drug formulation or any of its components;
• Intolerance to subcutaneous injection or other local skin abnormalities or dermatoses that may affect drug administration or safety assessment;
• Meeting any one of the following criteria during screening:
• Hemoglobin \<60 g/L;
• Platelet count \<100×10⁹/L;
• Abnormal hepatic or renal function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥2.5× upper limit of normal (ULN), or total bilirubin ≥1.5× ULN; or serum creatinine (Cr) ≥1.5× ULN;
• Positive for anti-human immunodeficiency virus (HIV) antibodies.
• Any bleeding disorder other than congenital Factor VII deficiency, or other conditions causing significantly abnormal coagulation parameters (e.g., hemophilia A or B, von Willebrand disease, platelet disorders, vitamin K deficiency, etc.);
• Protein C deficiency or Protein S deficiency;
• History of thrombosis, family history of thrombosis, or history of thrombophilia;
• Intracranial hemorrhage within 2 years prior to signing the informed consent form;
• Severe cardiac disease, such as unstable angina, congestive heart failure (New York Heart Association class ≥III), serious arrhythmia (QTc interval \>450 ms, corrected by Fridericia formula), uncontrolled hypertension (systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg), etc.;
• Female patients with menstrual abnormalities caused by organic gynecological conditions (e.g., uterine fibroids, endometriosis, adenomyosis, etc.);
• Received Factor VII-containing products within 48 hours prior to first administration of SR604 Injection; received whole blood or plasma transfusion within 2 weeks prior to first administration of SR604 Injection;
• Used any anticoagulants, antifibrinolytics, or agents affecting platelet function (including chemical drugs, biological products, or traditional Chinese medicine), including aspirin, within 1 week prior to screening, or required use of such agents during the treatment period;

Sponsors & Collaborators

• Shanghai RAAS Blood Products Co., Ltd.: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences

Tianjin, China

Location

MeSH Terms

Conditions

Factor VII Deficiency

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, Inherited; Blood Coagulation Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Coagulation Protein Disorders; Hemorrhagic Disorders; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Research and Development

CONTACT

862122130888; hanyu@raas-corp.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: July 17, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)