A Study of Recombinant AAV2/6 Human Factor 8 Gene Therapy SB-525 (PF-07055480) in Subjects With Severe Hemophilia A
NCT03061201 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13
Last updated 2025-09-30
Summary
The purpose of the study is to evaluate the safety, tolerability and time-course profile of FVIII activity after dosing with SB-525 (PF-07055480)
Conditions
Interventions
- BIOLOGICAL
-
SB-525 (PF-07055480)
Single dose of investigational product SB-525 (PF-07055480)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Pfizer CT.gov Call Center · Pfizer
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-06-21
- Primary Completion
- 2024-07-16
- Completion
- 2024-07-16
- FDA Drug
- Yes
Countries
- United States
Study Locations
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