← Back to Search

Monoclonal Antibodies

SR604 for Hemophilia

Phase 1
Recruiting
Research Sponsored by Equilibra Bioscience LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Part A: Body mass index between 18 and 30 kg/m^2, weighs >= 50 kg and <= 90 kg
Part A: No clinically significant findings on medical examination including physical examination, 12-lead electrocardiogram, and clinical laboratory tests
Must not have
Part B: Impaired cardiac function or clinically significant cardiac disease
Part B: Participants with a history of all types of thrombosis or related conditions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up part a: from baseline (day 1) till day 57; part b: from baseline (day 1) till day 90

Summary

This trial will test a new medication called SR604 in two groups of people. The first group will be healthy individuals to see how safe the medication is and how the body processes it. The second group

Who is the study for?
This trial is for individuals with severe Hemophilia A or B whose bleeding isn't controlled well by current treatments, and healthy subjects. Participants must have a BMI of 18-30 kg/m^2, weigh 50-90 kg, and have no significant medical issues. Men must use birth control during the study and for 90 days after.
What is being tested?
The study tests SR604's safety, how it's tolerated, its movement through and effects on the body (PK/PD) in healthy people (Part A), and those same factors plus effectiveness in those with severe Hemophilia A/B (Part B). Some will receive SR604; others a placebo.
What are the potential side effects?
While specific side effects are not listed here, common ones may include reactions at the injection site, headaches, nausea or allergic reactions. The trial aims to assess these potential side effects thoroughly.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My BMI is between 18 and 30, and I weigh between 50kg and 90kg.
Select...
My recent health checks, including heart and lab tests, show no significant issues.
Select...
I have severe Hemophilia A or B from birth.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have heart problems that affect my daily activities.
Select...
I have a history of blood clots or related conditions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~part a: from baseline (day 1) till day 57; part b: from baseline (day 1) till day 90
This trial's timeline: 3 weeks for screening, Varies for treatment, and part a: from baseline (day 1) till day 57; part b: from baseline (day 1) till day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Parts A and B: Number of Participants with Clinical Abnormal Changes in Coagulations Markers
Parts A and B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Secondary study objectives
Part A: Area Under the Serum Concentration-time Curve from time Zero Extrapolated to Infinity (AUC[0-inf])
Part A: Area Under the Serum Concentration-time Curve from time Zero to the Last Quantifiable Time Point (AUC[0-t])
Part A: Clearance Following Extravascular Administration (CL/F) of SR604
+10 more

Trial Design

8Treatment groups
Experimental Treatment
Group I: Part B: Cohort 4B (SR604 Dose 8)Experimental Treatment1 Intervention
Participants with severe Hemophilia A or Hemophilia B will receive SR604 dose 8 as SC injection.
Group II: Part B: Cohort 3B (SR604 Dose 7)Experimental Treatment1 Intervention
Participants with severe Hemophilia A or Hemophilia B will receive SR604 dose 7 as SC injection.
Group III: Part B: Cohort 2B (SR604 Dose 6)Experimental Treatment1 Intervention
Participants with severe Hemophilia A or Hemophilia B will receive SR604 dose 6 as SC injection.
Group IV: Part B: Cohort 1B (SR604 Dose 5)Experimental Treatment1 Intervention
Participants with severe Hemophilia A or Hemophilia B will receive SR604 dose 5 as SC injection.
Group V: Part A: Cohort 4A (SR604 Dose 4)Experimental Treatment2 Interventions
Participants will receive single SC dose of SR604 dose 4 or matching placebo to SR604 on Day 1.
Group VI: Part A: Cohort 3A (SR604 Dose 3)Experimental Treatment2 Interventions
Participants will receive single SC dose of SR604 dose 3 or matching placebo to SR604 on Day 1.
Group VII: Part A: Cohort 2A (SR604 Dose 2)Experimental Treatment2 Interventions
Participants will receive single SC dose of SR604 dose 2 or matching placebo to SR604 on Day 1.
Group VIII: Part A: Cohort 1A (SR604 Dose 1)Experimental Treatment2 Interventions
Participants will receive single subcutaneous (SC) dose of SR604 dose 1 or matching placebo to SR604 on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Placebo
1995
Completed Phase 3
~2670

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Equilibra Bioscience LLCLead Sponsor
~30 spots leftby May 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top