Trials / Recruiting
RecruitingNCT06349473
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 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)
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 31 (estimated)
- Sponsor
- Equilibra Bioscience LLC · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
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).
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SR604 | SR604 will be administered as SC injection. |
| DRUG | Placebo | Placebo will be administered as single SC injection. |
Timeline
- Start date
- 2024-05-10
- Primary completion
- 2026-09-28
- Completion
- 2026-09-28
- First posted
- 2024-04-05
- Last updated
- 2026-03-10
Locations
10 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06349473. Inclusion in this directory is not an endorsement.