A Study of SR604 for Hemophilia A, Hemophilia B, or Factor VII Deficiency
This study is testing a new drug called SR604, given as a shot under the skin. It aims to understand how safe SR604 is, how well your body handles it (tolerability), and how it moves through and affects your body (pharmacokinetics and pharmacodynamics). The study includes healthy volunteers and people with Hemophilia A, Hemophilia B, or Factor VII (FVII) deficiency. Researchers will be looking for any side effects and changes in blood clotting markers. You may be eligible if you are between 18 and 60 years old. The study is currently recruiting about 31 participants, but its overall status is unclear.
- Study design
- This is a first-in-human interventional study with two parts. Part A involves healthy participants receiving either SR604 or a placebo, while Part B involves participants with hemophilia or FVII deficiency receiving SR604.
- What's involved
- The overall study participation will last approximately 3 months. You would receive SR604 or placebo as a subcutaneous (under the skin) injection.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants in Part A will be followed for safety up to Day 57, and participants in Part B will be followed for safety up to 3 months after starting the study.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
NCT06349473
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)
Recruiting
PHASE1Ages 18–60InterventionalTreatmentEquilibra Bioscience LLC
~31 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:SR604Placebo
At a glance
Recruiting sites
8 of 10 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Parts A and B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Measured over Part A: From Baseline (Day 1) up to Day 57; Part B: From Baseline (Day 1) up to 3 months
+1 more outcome measured
Conditions
Where it's being run
10 sites across 8 statesCalifornia2
Pennsylvania2
Illinois1
Louisiana1
Michigan1
Missouri1
North Carolina1
Ontario1
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
Male participants aged 18 to 55 years, inclusive.
Body mass index between 18 and 30 kilograms per meter square (kg/m\^2), inclusive, and weighs greater than or equal to (\>=) 50 kilograms (kg), less than or equal to (\<=) 90 kg.
No clinically significant findings on medical examination, including physical examination, 12-lead electrocardiogram, and clinical laboratory tests.
Sexually active men must commit to use an effective method of birth control while taking the study intervention and for 90 days after the dose of study intervention.
Male and female participants (only female participants with congenital FVII deficiency) aged 18 to 60 years, inclusive.
Participants must have one of the following bleeding disorders: Severe hemophilia A (\<1% Factor VIII \[FVIII\]); or Severe and/or moderately severe Hemophilia B (≤ 2% Factor IX \[FIX\]); or Severe FVII deficiency (\<10% FVII activity). Participants with severe FVII deficiency must satisfy with either of following criteria:
Participants with Hemophilia A or Hemophilia B must satisfy either of the following criteria:
Medical records documenting a minimum of 2 years of bleeding event history.
Willing to undergo a weaning period from prior treatment or prophylaxis for Hemophilia A or Hemophilia B or FVII deficiency.
Sexually active men must commit to use an effective method of birth control while taking the study intervention and for 90 days after the dose of SR604.
Women of childbearing potential must have a negative pregnancy test at the Screening Visit and agree to follow the contraception guidance during the intervention period and for at least 90 days after the last dose of SR604.
Exclusion
Participant has clinically significant history or evidence of cardiovascular, respiratory (including all chronic lung diseases), hepatic, renal, gastrointestinal, endocrine, neurological, immunological, bleeding, or psychiatric disorder(s).
Participant has a mean pulse less than (\<) 40 or greater than (\>) 90 beats per minute (bpm), mean systolic blod pressure (BP) \< 90 millimeter of mercury (mmHg) or \> 140 mmHg, or mean diastolic BP \< 50 mmHg or \> 90 mmHg at the screening visit.
Participant has a mean corrected QT corrected for heart rate by Fridericia's formula (QTcF) of \> 450 msec at the Screening Visit.
Participant has had injury, trauma, and/or major surgery within 3 months before Screening, or is planned to undergo surgery during the study.
Participant has received vaccination within 14 days before the dose of study intervention or has a vaccination planned during the study.
History of one or more of the following in participants and/or family members:
History of clinically significant intracranial hemorrhage, pneumonia, chronic liver disease, liver or kidney transplants, or malignant diseases.
Any medical condition (eg, diabetes, obesity.) which, in the Investigator's opinion, could compromise participant safety, interfere with study intervention metabolism, or put the study outcome at undue risk. Any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the participant or could prevent, limit or confound protocol-specified assessments.
Participants with a history of all types of thrombosis, including any arterial and/or venous thrombosis, superficial thrombophlebitis, or embolism. Additionally, participants with a history of thrombotic microangiopathy, stroke, and transient ischemic attack (TIA), or abnormal findings in any prior laboratory thrombophilia evaluation will be excluded.
Participants with a history of all types of thrombosis, including any arterial and/or venous thrombosis, superficial thrombophlebitis, or embolism. Additionally, participants with a history of thrombotic microangiopathy, stroke, and TIA, or abnormal findings in any prior laboratory thrombophilia evaluation will be excluded.
History of one or more of the following in participants and/or family members:
Impaired cardiac function or clinically significant cardiac disease, including any of the following:
Uncontrolled hypertension (systolic BP \> 150 mmHg and diastolic BP \> 100 mmHg), a history of hypertension crisis, or a history of hypertensive encephalopathy.
Participant with the following laboratory abnormalities:
Calculated creatinine clearance ˂ 60 mL/min using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula at the Screening Visit.
Participant has positive test result for human immunodeficiency virus (HIV) antibody.
Chronic liver disease (Child-Pugh class C hepatic impairment), or history of liver or kidney transplants.
Injury, trauma, and/or major surgery (mediastinoscopy, insertion of a central venous access device, and insertion of a feeding tube are not considered major surgery), major dental procedures (extractions, etc.) within 4 weeks of the first dose of SR604 or planned surgery during the study.
Active infection requiring systemic antibiotic or antiviral therapy or in a sepsis condition within 14 days prior to the first dose of SR604.
Any medical condition (eg, diabetes, obesity) which, in the Investigator's opinion, could compromise participant safety, interfere with SR604 metabolism, or put the study outcome at undue risk.
Female participants who are pregnant or are currently breastfeeding or planning to become pregnant while enrolled in this study or within 90 days after the last dose of SR604.
What this trial measures
- Parts A and B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)Part A: From Baseline (Day 1) up to Day 57; Part B: From Baseline (Day 1) up to 3 months
Safety and tolerability of a single ascending SC dose of SR604 in healthy participants and multiple ascending SC doses of SR604 in participants with Hemophilia A or Hemophilia B or FVII deficiency will be evaluated.
- Parts A and B: Number of Participants with Clinical Abnormal Changes in Coagulations MarkersPart A: From Baseline (Day 1) till Day 57; Part B: From Baseline (Day 1) till Day 90
Safety and tolerability of a single ascending SC dose of SR604 in healthy participants and multiple ascending SC doses of SR604 in participants with Hemophilia A or Hemophilia B or FVII deficiency will be evaluated.