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Healthy ParticipantsPhase 1NCT06349473

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)

A Phase 1 study testing SR604 in people with Healthy Participants and Hemophilia A, run by Equilibra Bioscience LLC at 10 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Participants, Hemophilia A, Hemophilia B
What is being tested?
SR604
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
31 participants
Where
10 sitesin 2 countries
Study dates
10 May 2024to 28 Sep 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Part A:
  • 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.
  • Part B:
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  • 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 history of >2 bleeding events in the last 12 months require on-demand treatment with recombinant factor VIIa (rFVIIa) or plasma-derived FVII concentrates (pd-FVII) or fresh frozen plasma (FFP) for bleeding control.
  • Participants on prophylaxis treatment with rFVIIa or pd-FVII or FFP regardless of bleeding history.
  • Participants with Hemophilia A or Hemophilia B must satisfy either of the following criteria:
  • Participants not on prophylaxis must have a documented ABR of 6 in 12 months before screening.
  • Participants on prophylaxis must have a documented ABR of ≥ 2 in 12 months before screening.
  • Intolerant to current treatment regimen.
  • 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.

Who cannot join

  • Part A:
  • 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.
Show all 40Show fewer
  • History of one or more of the following in participants and/or family members:
  • Factor V (FV) Leiden mutation.
  • Activated protein C (APC) resistant.
  • Protein C (PC) or protein S (PS) deficiency.
  • Prothrombin 20210 mutation;
  • Antithrombin III (ATIII) deficiency.
  • 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.
  • Part B:
  • 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:
  • FV Leiden mutation.
  • APC resistant.
  • PC or PS deficiency.
  • Prothrombin 20210 mutation.
  • ATIII deficiency.
  • Impaired cardiac function or clinically significant cardiac disease, including any of the following:
  • Clinically significant and/or uncontrolled heart disease such as congestive heart failure requiring treatment (New York Heart Association Grade >=2), left ventricular ejection fraction < 50% as determined by multiple gated acquisition or echocardiogram, or clinically significant arrhythmia.
  • QTcF > 450 ms ECG or congenital Long QT Syndrome at the Screening Visit.
  • Acute myocardial infarction or unstable angina pectoris < 3 months prior to study entry.
  • 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:
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 1.5 × upper limit of normal (ULN);
  • Total bilirubin ˃3.0 × ULN and direct bilirubin ˃1.5 × ULN (unless due to Gilbert's syndrome).
  • 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.
  • If participants test positive for hepatitis B core antibody (HBcAb), additional tests including hepatitis B surface antibody, hepatitis B surface antigen (HBsAg), and hepatitis B viral deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) will be conducted to determine if there is an active infection. Participants with active infection will be excluded from the study.
  • Participants who test positive for hepatitis C virus antibody will be required to have a negative result for hepatitis C viral ribonucleic acid (RNA) PCR before enrollment. Individuals with positive results for hepatitis C PCR will be excluded from the study.
  • 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.

Trial locations and contacts

10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Clinical Trials contact

925-490-0278

inf@equilibrabioscience.com

10 sites in 2 countries

United States9 sites, 8 recruiting

  • University of Michigan Hospitals - Michigan Medicine

    Ann Arbor, Michigan, 48109

    Recruiting

  • Rush University Medical Center

    Chicago, Illinois, 60612

    Recruiting

  • California Clinical Trials Medical Group (CCTMG)

    Glendale, California, 91206

    Completed

  • Brody School of Medicine at East Carolina University

    Greenville, North Carolina, 27834

    Not yet recruiting

  • Penn State Milton S Hershey Medical Center Pediatrics

    Hershey, Pennsylvania, 17033

    Recruiting

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027

    Recruiting

  • LA Center for Bleeding and Clotting Disorders - Metairie

    Metairie, Louisiana, 70001

    Recruiting

  • Perelman Center for Advanced Medicine (PCAM)- Penn Blood Disorders Program

    Philadelphia, Pennsylvania, 19104

    Recruiting

  • Washington University School of Medicine

    St Louis, Missouri, 63110

    Recruiting

Other trials in United States

Canada1 site, 1 recruiting

  • McMaster University Medical Centre, Hamilton Health Sciences

    Hamilton, Ontario, L8N 3Z5

    Recruiting

Other trials in Canada

About this study

Official title: A Phase 1 Single and Multiple Dose-Escalation Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SR604 in Healthy Participants (Part A) and the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SR604 in Participants With Hemophilia A or Hemophilia B or Factor VII Deficiency (Part B)

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).

Read the detailed description

This is a first-in-human (FIH) study to be conducted with SR604. The study will enroll healthy participants (Part A) and participants with Hemophilia A or Hemophilia B or FVII deficiency (Part B).

In Part A (single ascending dose [SAD]): Healthy participants will be randomized in a 2:1 ratio in each of the 3 to 4 (Cohort 4 is optional) sequential cohorts. All cohorts will include participants receiving active treatment with SR604 and the other participant receiving matching placebo.

In Part B (multiple ascending dose [MAD]): Participants with Hemophilia A or Hemophilia B or FVII deficiency, with or without inhibitors, will be enrolled in 4 cohorts with four dose levels and is planned to receive SR604 subcutaneously.

The overall duration of study participation will be approximately 3 months.

Being tested
SR604, Placebo
Keywords
Single ascending dose, Multiple ascending dose, Factor IX, Factor VIII, Factor VII
Medical subject headings
Hemophilia A, Hemophilia B, Factor VII Deficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SR604Drug

    SR604 will be administered as SC injection.

  • PlaceboDrug

    Placebo will be administered as single SC injection.

Study groups in NCT06349473
Study groupRoleWhat they receive
Part A: Cohort 1A (SR604 Dose 1)ExperimentalParticipants will receive single subcutaneous (SC) dose of SR604 dose 1 or matching placebo to SR604 on Day 1.
Receives: Drug: SR604; Drug: Placebo
Part A: Cohort 2A (SR604 Dose 2)ExperimentalParticipants will receive single SC dose of SR604 dose 2 or matching placebo to SR604 on Day 1.
Receives: Drug: SR604; Drug: Placebo
Part A: Cohort 3A (SR604 Dose 3)ExperimentalParticipants will receive single SC dose of SR604 dose 3 or matching placebo to SR604 on Day 1.
Receives: Drug: SR604; Drug: Placebo
Part A: Cohort 4A (SR604 Dose 4)ExperimentalParticipants will receive single SC dose of SR604 dose 4 or matching placebo to SR604 on Day 1.
Receives: Drug: SR604; Drug: Placebo
Part B: Cohort 1B (SR604 Dose 5)ExperimentalParticipants with Hemophilia A or Hemophilia B or FVII deficiency will receive SR604 dose 5 as multiple SC injections every 4-weeks.
Receives: Drug: SR604
Part B: Cohort 2B (SR604 Dose 6)ExperimentalParticipants with Hemophilia A or Hemophilia B or FVII deficiency will receive SR604 dose 6 as multiple SC injections every 4-weeks.
Receives: Drug: SR604
Part B: Cohort 3B (SR604 Dose 7)ExperimentalParticipants with Hemophilia A or Hemophilia B or FVII deficiency will receive SR604 dose 7 as multiple SC injections every 4-weeks.
Receives: Drug: SR604
Part B: Cohort 4B (SR604 Dose 8)ExperimentalParticipants with Hemophilia A or Hemophilia B or FVII deficiency will receive SR604 dose 8 as multiple SC injections every 4-weeks.
Receives: Drug: SR604

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Parts A and B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    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.

    Measured: Part A: From Baseline (Day 1) up to Day 57; Part B: From Baseline (Day 1) up to 3 months

  2. Parts A and B: Number of Participants with Clinical Abnormal Changes in Coagulations Markers

    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.

    Measured: Part A: From Baseline (Day 1) till Day 57; Part B: From Baseline (Day 1) till Day 90

Secondary outcomes (12)

  1. Part A: Area Under the Serum Concentration-time Curve from time Zero to the Last Quantifiable Time Point (AUC[0-t])

    The PK profile (AUC[0-t]) of a single ascending SC dose of SR604 in healthy participants will be assessed.

    Measured: From Baseline (Day 1) up to Day 57

  2. Part A: Area Under the Serum Concentration-time Curve from time Zero Extrapolated to Infinity (AUC[0-inf])

    The PK profile (AUC[0-inf]) of a single ascending SC dose of SR604 in healthy participants will be assessed.

    Measured: From Baseline (Day 1) up to Day 57

  3. Parts A and B: Maximum Concentration (Cmax) of SR604

    The PK profile (Cmax) of a single ascending and multiple ascending SC dose of SR604 will be assessed.

    Measured: Part A: From Baseline (Day 1) up to Day 57; Part B: From Baseline (Day 1) up to Day 90

  4. Parts A and B: Time to Maximum Concentration (tmax) of SR604

    The PK profile (tmax) of a single ascending and multiple ascending SC dose of SR604 will be assessed.

    Measured: Part A: From Baseline (Day 1) up to Day 57; Part B: From Baseline (Day 1) up to Day 90

  5. Parts A and B: Terminal Half-life (T1/2) of SR604

    The PK profile (T1/2) of a single ascending and multiple ascending SC dose of SR604 will be assessed.

    Measured: Part A: From Baseline (Day 1) up to Day 57; Part B: From Baseline (Day 1) up to Day 90

  6. Part A: Clearance Following Extravascular Administration (CL/F) of SR604

    The PK profile (CL/F) of a single ascending SC dose of SR604 in healthy participants will be assessed.

    Measured: From Baseline (Day 1) up to Day 57

  7. Part A: Volume of Distribution in Terminal Phase Following Extravascular Administration (Vz/F) of SR604

    The PK profile (Vz/F) of a single ascending SC dose of SR604 in healthy participants will be assessed.

    Measured: From Baseline (Day 1) up to Day 57

  8. Parts B: Concentration before the next dose administration (Ctrough)

    The PK profile (Ctrough) of SR604 following repeated SC injections will be assessed.

    Measured: From Baseline (Day 1) up to Day 90

  9. Parts B: Accumulation Ratio (R) of SR604

    The PK profile (accumulation R) of SR604 following repeated SC injections will be assessed.

    Measured: From Baseline (Day 1) up to Day 90

  10. Parts B: Number of Bleeding Events

    The preliminary clinical activity of SR604 will be assessed. Bleeding event (record traumatic or non-traumatic bleeding, number of bleeding sites [joints or non-joints], bleeding frequency (intervals), associated with any external triggers, level of physical activity) will be evaluated.

    Measured: From Baseline (Day 1) up to 3 months

  11. Parts B: Annualized Bleeding Rate (ABR) in Body and Targeted Joints

    The preliminary clinical activity of SR604 will be assessed. ABR in body and targeted joined will be evaluated.

    Measured: From Baseline (Day 1) up to 3 months

  12. Parts A and B: Number of Participants with Positive Antidrug Antibodies (ADAs)

    Number of participants with positive ADAs will be assessed.

    Measured: Part A: From Baseline (Day 1) till Day 57; Part B: From Baseline (Day 1) till Day 90

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Apr 2024
  2. Study start10 May 2024
  3. Primary completion28 Sep 2026 (estimated)
  4. Study completion28 Sep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Sequential
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
31 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06349473
Sponsor's protocol ID
SR604-1
Status last verified
Jun 2026
First submitted
20 Mar 2024
Last updated
2 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SR604 in people with Healthy Participants and Hemophilia A, run by Equilibra Bioscience LLC at 10 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 40 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Clinical Trials (925-490-0278, inf@equilibrabioscience.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Parts A and B: Number of Participants with Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) (time frame: Part A: From Baseline (Day 1) up to Day 57; Part B: From Baseline (Day 1) up to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06349473.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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