Actively 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)
Led by Equilibra Bioscience LLC · Updated on 2026-03-10
31
Participants Needed
10
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male participants aged 18 to 55 years for Part A
- Body mass index between 18 and 30 kg/m2 and weight between 50 and 90 kg for Part A
- No clinically significant medical findings for Part A
- Sexually active men must agree to use effective birth control during and for 90 days after treatment
- Male and female participants aged 18 to 60 years for Part B (females only with congenital FVII deficiency)
- Diagnosed with severe hemophilia A, severe or moderately severe hemophilia B, or severe FVII deficiency with specific bleeding history or prophylaxis treatment for Part B
- Documented bleeding history for at least 2 years for Part B
- Willing to undergo weaning from prior treatments for Part B
- Women of childbearing potential must test negative for pregnancy at screening and agree to contraception during and for 90 days after treatment
You will not qualify if you...
- History or evidence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, bleeding, or psychiatric disorders for Part A
- Abnormal vital signs or ECG measures at screening for Part A
- Recent injury, trauma, major surgery, or vaccination before or during the study for Part A
- History of thrombosis, thrombophilia mutations, or related conditions for both parts
- Impaired cardiac function or significant heart disease for Part B
- Uncontrolled hypertension or hypertensive crisis history for Part B
- Liver enzyme or kidney function abnormalities for Part B
- Positive HIV test or active hepatitis infection for Part B
- Chronic liver disease or history of organ transplant for Part B
- Recent major surgery or active infection before dosing for Part B
- Any medical condition that could risk participant safety or interfere with the study
- Pregnant or breastfeeding women or those planning pregnancy during or within 90 days after the study for Part B
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
California Clinical Trials Medical Group (CCTMG)
Glendale, California, United States, 91206
Completed
2
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
3
Rush University Medical Center
Chicago, Illinois, United States, 60612
Not Yet Recruiting
4
LA Center for Bleeding and Clotting Disorders - Metairie
Metairie, Louisiana, United States, 70001
Actively Recruiting
5
University of Michigan Hospitals - Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
6
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
7
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States, 27834
Not Yet Recruiting
8
Penn State Milton S Hershey Medical Center Pediatrics
Hershey, Pennsylvania, United States, 17033
Not Yet Recruiting
9
Perelman Center for Advanced Medicine (PCAM)- Penn Blood Disorders Program
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
10
McMaster University Medical Centre, Hamilton Health Sciences
Hamilton, Ontario, Canada, L8N 3Z5
Actively Recruiting
Research Team
C
Clinical Trials
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
8
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