A Study To Investigate The Pharmacokinetics, Safety, And Tolerability Of Subcutaneous Ocrelizumab Administration In Participants With Multiple Sclerosis
NCT03972306 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 134
Last updated 2025-07-08
Summary
This study will evaluate the pharmacokinetics, safety and tolerability, and immunogenicity of ocrelizumab administered subcutaneously to participants with multiple sclerosis (MS).
Conditions
- Multiple Sclerosis (MS)
Interventions
- DRUG
-
Ocrelizumab
Administered by subcutaneous Injection
- DRUG
-
Ocrelizumab
Administered by Intravenous (IV) Injection
- DRUG
-
rHuPH20
Administered in a 2-mL glass vial as a sterile, single-use, injectable liquid to be manually mixed with SC ocrelizumab
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Clinical Trials · Hoffmann-La Roche
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-08-12
- Primary Completion
- 2025-06-03
- Completion
- 2025-06-03
- FDA Drug
- Yes
Countries
- United States
Study Locations
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