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RECRUITING
NCT06349473
PHASE1

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)

Sponsor: Equilibra Bioscience LLC

View on ClinicalTrials.gov

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 or without inhibitors (Part B).

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)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

31

Start Date

2024-05-10

Completion Date

2026-09-28

Last Updated

2026-03-10

Healthy Volunteers

Yes

Interventions

DRUG

SR604

SR604 will be administered as SC injection.

DRUG

Placebo

Placebo will be administered as single SC injection.

Locations (10)

California Clinical Trials Medical Group (CCTMG)

Glendale, California, United States

Children's Hospital Los Angeles

Los Angeles, California, United States

Rush University Medical Center

Chicago, Illinois, United States

LA Center for Bleeding and Clotting Disorders - Metairie

Metairie, Louisiana, United States

University of Michigan Hospitals - Michigan Medicine

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

Brody School of Medicine at East Carolina University

Greenville, North Carolina, United States

Penn State Milton S Hershey Medical Center Pediatrics

Hershey, Pennsylvania, United States

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

Philadelphia, Pennsylvania, United States

McMaster University Medical Centre, Hamilton Health Sciences

Hamilton, Ontario, Canada