Study identifier:CD-IA-MEDI-551-1102
ClinicalTrials.gov identifier:NCT01585766
EudraCT identifier:N/A
CTIS identifier:N/A
A Phase 1 Randomized Study of MEDI-551 in Subjects with Relapsing Forms of Multiple Sclerosis
Multiple Sclerosis, Relapsing forms
Phase 1
No
MEDI-551 30 MG-IV, MEDI-551 60 MG-SC, PLACEBO-IV-SC, MEDI-551 100 MG-IV, MEDI-551 300 MG-SC, MEDI-551 600 MG-IV
All
56
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety
Intervention Model: Parallel Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Feb 2018 by MedImmune, LLC
MedImmune, LLC
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: MEDI-551 30 MG-IV Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15. | Drug: MEDI-551 30 MG-IV Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15. |
Experimental: MEDI-551 60 MG-SC Participants received SC injection of 60 mg MEDI-551 on Day 1. | Drug: MEDI-551 60 MG-SC Participants received SC injection of 60 mg MEDI-551 on Day 1. |
Experimental: MEDI-551 100 MG-IV Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15. | Drug: MEDI-551 100 MG-IV Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15. |
Experimental: MEDI-551 300 MG-SC Participants received SC injection of 300 mg MEDI-551 on Day 1. | Drug: MEDI-551 300 MG-SC Participants received SC injection of 300 mg MEDI-551 on Day 1. |
Experimental: MEDI-551 600 MG-IV Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15. | Drug: MEDI-551 600 MG-IV Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15. |
Placebo Comparator: PLACEBO-IV-SC Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1. | Drug: PLACEBO-IV-SC Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1 |