Conditions: Multiple Sclerosis, Relapsing Forms
Keywords: MAb, B cell, depletion, RMS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 56
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the safety and tolerability of ascending intravenous (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of multiple sclerosis (MS).

Detailed description:
This is a Phase 1, multicenter, multinational, randomized, blinded, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of IV and SC doses of MEDI-551 in adult subjects with relapsing forms of MS.

Arms:
arm 1: Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15. arm 2: Participants received SC injection of 60 mg MEDI-551 on Day 1. arm 3: Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15. arm 4: Participants received SC injection of 300 mg MEDI-551 on Day 1. arm 5: Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15. arm 6: Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1.

Interventions: intervention 1: MEDI-551 30 MG-IV intervention 2: MEDI-551 60 MG-SC intervention 3: PLACEBO-IV-SC intervention 4: MEDI-551 100 MG-IV intervention 5: MEDI-551 300 MG-SC intervention 6: MEDI-551 600 MG-IV
Intervention descriptions: intervention 1: Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15. intervention 2: Participants received SC injection of 60 mg MEDI-551 on Day 1. intervention 3: Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1 intervention 4: Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15. intervention 5: Participants received SC injection of 300 mg MEDI-551 on Day 1. intervention 6: Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.

Protocol document: