Actively Recruiting
A Phase 1 Study of SR604 to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy in Healthy Adults and Adults With Hemophilia A, Hemophilia B, or Factor VII Deficiency
Led by Equilibra Bioscience LLC · Updated on 2026-03-10
31
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the drug SR604 in both healthy adults and individuals with Hemophilia A, Hemophilia B, or Factor VII deficiency. The study aims to evaluate the safety, tolerability, how the drug moves and works in the body, and its effectiveness in treating these bleeding disorders. This first-in-human trial includes a phase for healthy participants as well as a phase for affected participants, with both groups monitored closely for any adverse events or changes in blood clotting markers. In the first part, healthy participants receive a single subcutaneous injection of SR604 or a placebo in ascending doses across multiple groups. In the second part, participants with the bleeding disorders receive multiple subcutaneous injections of SR604 every four weeks at increasing dose levels. The study uses a randomized and double-blind design to compare SR604 with placebo for healthy participants, while affected participants receive only SR604. The total study participation lasts about three months. During the study, participants undergo medical examinations, blood tests, and monitoring for treatment-related side effects and changes in blood coagulation. Researchers assess drug levels in the blood at various times and track bleeding events in participants with bleeding disorders. Safety is closely monitored through adverse event reporting and antibody testing. Participants also provide medical history and may undergo a treatment weaning period before starting SR604. The study measures responses up to three months from the first dose to understand the drug's effects and safety profile.
CONDITIONS
Brief 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 with BMI 18 to 30 kg/m2 and weight between 50 and 90 kg for Part A (healthy participants)
- No clinically significant medical findings and agree to use effective birth control during and after the study for Part A
- Male and female participants aged 18 to 60 years with severe Hemophilia A, Hemophilia B, or severe Factor VII deficiency for Part B
- Documented bleeding disorder history with specified bleeding rates or treatment intolerance for Part B
- Willingness to undergo weaning from prior treatment for Part B
- Women of childbearing potential must have a negative pregnancy test and agree to contraception during and after the study for Part B
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 findings at screening for Part A
- Recent injury, surgery, or vaccination before study for Part A
- History of thrombosis, thrombophilia mutations, or clotting disorders for both parts
- Impaired cardiac function or serious heart disease for Part B
- Uncontrolled hypertension or recent acute heart events for Part B
- Significant liver or kidney disease and abnormal laboratory results for Part B
- Positive tests for HIV, active hepatitis B or C infection for Part B
- Pregnancy, breastfeeding, or planning pregnancy during or shortly after the study for female participants in Part B
- Any condition posing undue risk or interfering with study participation or outcomes as judged by the investigator in both parts
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 months
Participants receive either a single subcutaneous injection of SR604 or matching placebo in Part A, or multiple subcutaneous injections of SR604 every 4 weeks in Part B.
1 visit on Day 1 for Part A; multiple visits every 4 weeks for Part B
Duration - Up to approximately 3 months total study participation
Participants are monitored for safety, pharmacokinetics, pharmacodynamics, and efficacy after treatment completion.
Visits as scheduled for safety and efficacy assessments up to Day 57 for Part A and Day 90 for Part B
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
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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