RecruitingPhase 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)

United States31 participantsStarted 2024-05-10

Plain-language 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).

Who can participate

Age range18 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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 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.

Exclusion criteria

✕. 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.
✕. FV Leiden mutation.
✕. APC resistant.
✕. PC or PS deficiency.

What they're measuring

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

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

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

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

Trial details

NCT IDNCT06349473

SponsorEquilibra Bioscience LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-09-28

Contact for this trial

Clinical Trials

925-490-0278 inf@equilibrabioscience.com

View on ClinicalTrials.gov More Healthy Participants trials