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NCT06349473 · ClinicalTrials.gov registry record · Phase 1
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 of Healthy Participants and Hemophilia A, sponsored by Equilibra Bioscience.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 31
- Enrollment target
- 10
- Study locations
NCT06349473: Recruiting Phase 1 study of Healthy Participants and Hemophilia A, sponsored by Equilibra Bioscience.
NCT06349473 is a Phase 1 study of Healthy Participants and Hemophilia A that is actively recruiting participants, run by Equilibra Bioscience. The registered enrollment target is 31 participants, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (52% lower). The trial reports 10 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06349473, a Phase 1 study of Healthy Participants and Hemophilia A, is actively recruiting participants, sponsored by Equilibra Bioscience.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 31 participants
- Enrollment target
- 10
- Study locations
Study 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).
Primary Outcome
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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG SR604
Study Locations (10)
California
- California Clinical Trials Medical Group (CCTMG) - Glendale
- Children's Hospital Los Angeles - Los Angeles
Pennsylvania
- Penn State Milton S Hershey Medical Center Pediatrics - Hershey
- Perelman Center for Advanced Medicine (PCAM)- Penn Blood Disorders Program - Philadelphia
Illinois
- Rush University Medical Center - Chicago
Louisiana
- LA Center for Bleeding and Clotting Disorders - Metairie - Metairie
Michigan
- University of Michigan Hospitals - Michigan Medicine - Ann Arbor
Missouri
- Washington University School of Medicine - St Louis
North Carolina
- Brody School of Medicine at East Carolina University - Greenville
Ontario
- McMaster University Medical Centre, Hamilton Health Sciences - Hamilton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 31 participants |
| Start Date | 2024-05-10 |
| Est. Completion | 2026-09-28 |
| Phase | Phase 1 |
What NCT06349473 shows while recruiting
NCT06349473 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 31 participants, a relatively small participant target, below the 65-participant average among 119 other Healthy Participants trials with a reported enrollment target (52% lower).
The record links to 4 conditions, with Healthy Participants appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06349473 lists 10 locations in 8 states (California, Pennsylvania, Illinois).
Frequently Asked Questions
What is clinical trial NCT06349473 about?
NCT06349473 is a clinical study titled "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)". 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)...
What is the current status of trial NCT06349473?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 31 participants. The study started on 2024-05-10. Estimated completion is 2026-09-28.
What conditions does trial NCT06349473 study?
This clinical trial studies the following conditions: Healthy Participants, Hemophilia A, Hemophilia B, Factor VII Deficiency.
What interventions are being tested in trial NCT06349473?
The interventions under investigation include: Placebo (DRUG), SR604 (DRUG).
Who is sponsoring clinical trial NCT06349473?
This trial is sponsored by Equilibra Bioscience, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06349473 being conducted?
This trial has 10 study locations across California, Illinois, Louisiana, Michigan, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06349473's enrollment target sits among peer trials
31 70th of 119 higher than 49 of 119 other Healthy Participants trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Participants trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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