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)

Part of paid clinical trials in Glendale, California.

Sponsor
Equilibra Bioscience LLC
Study ID
NCT06349473
Phase
PHASE1
Status
Recruiting
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Conditions

  • Factor VII Deficiency
  • Healthy Participants
  • Hemophilia A
  • Hemophilia B

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Accepted

Interventions

  • SR604 — DRUG
    SR604 will be administered as SC injection.
  • Placebo — DRUG
    Placebo will be administered as single SC injection.

Study Details

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).

Key Dates

Start date
May 10, 2024
Status verified
Mar 2026
Primary completion
Sep 28, 2026
Completion
Sep 28, 2026

Study Design

Enrollment
31 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part A: Cohort 1A (SR604 Dose 1)
    Participants will receive single subcutaneous (SC) dose of SR604 dose 1 or matching placebo to SR604 on Day 1.
  • Experimental: Part A: Cohort 2A (SR604 Dose 2)
    Participants will receive single SC dose of SR604 dose 2 or matching placebo to SR604 on Day 1.
  • Experimental: Part A: Cohort 3A (SR604 Dose 3)
    Participants will receive single SC dose of SR604 dose 3 or matching placebo to SR604 on Day 1.
  • Experimental: Part A: Cohort 4A (SR604 Dose 4)
    Participants will receive single SC dose of SR604 dose 4 or matching placebo to SR604 on Day 1.
  • Experimental: Part B: Cohort 1B (SR604 Dose 5)
    Participants with Hemophilia A or Hemophilia B or FVII deficiency will receive SR604 dose 5 as multiple SC injections every 4-weeks.
  • Experimental: Part B: Cohort 2B (SR604 Dose 6)
    Participants with Hemophilia A or Hemophilia B or FVII deficiency will receive SR604 dose 6 as multiple SC injections every 4-weeks.
  • Experimental: Part B: Cohort 3B (SR604 Dose 7)
    Participants with Hemophilia A or Hemophilia B or FVII deficiency will receive SR604 dose 7 as multiple SC injections every 4-weeks.
  • Experimental: Part B: Cohort 4B (SR604 Dose 8)
    Participants with Hemophilia A or Hemophilia B or FVII deficiency will receive SR604 dose 8 as multiple SC injections every 4-weeks.

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 ]

Central Contacts

Locations (9)

FacilityCityStateZIPSite coordinators
California Clinical Trials Medical Group (CCTMG)GlendaleCalifornia91206-
Children's Hospital Los AngelesLos AngelesCalifornia90027-
Rush University Medical CenterChicagoIllinois60612-
LA Center for Bleeding and Clotting Disorders - MetairieMetairieLouisiana70001-
University of Michigan Hospitals - Michigan MedicineAnn ArborMichigan48109-
Washington University School of MedicineSt LouisMissouri63110-
Brody School of Medicine at East Carolina UniversityGreenvilleNorth Carolina27834-
Penn State Milton S Hershey Medical Center PediatricsHersheyPennsylvania17033-
Perelman Center for Advanced Medicine (PCAM)- Penn Blood Disorders ProgramPhiladelphiaPennsylvania19104-

Find similar trials in Glendale, CA

By research site
California Clinical Trials Medical Group (CCTMG)· Glendale, CAChildren's Hospital Los Angeles· Los Angeles, CARush University Medical Center· Chicago, ILLA Center for Bleeding and Clotting Disorders - Metairie· Metairie, LAUniversity of Michigan Hospitals - Michigan Medicine· Ann Arbor, MIWashington University School of Medicine· St Louis, MO

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