NCT01808482View on ClinicalTrials.gov

A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS)

PHASE1TerminatedINTERVENTIONAL
Enrollment

16

Participants

Timeline

Start Date

March 13, 2013

Primary Completion Date

August 6, 2013

Study Completion Date

August 6, 2013

Conditions
Multiple Sclerosis, Relapsing-Remitting
Interventions
DRUG

Part A: 100 mg/mL GSK2618960

100 mg/mL GSK2618960 solution for IV Infusion up to 1 hr except for the 1st dose (IV bolus) and 2nd dose (IV infusion over 5 min) of Part A

DRUG

Part A: matching placebo

Matching placebo

DRUG

Part B: Dose of GSK2618960 decided from Part A

100 mg/mL GSK2618960 solution for IV Infusion in repeat dose decided from Part A

DRUG

Part B: matching placebo

Matching placebo

DRUG

Part C: Dose of GSK2618960 decided from Part A and B

100 mg/mL GSK2618960 solution for IV Infusion in repeat dose decided from Part A and B

Trial Locations (1)

CB2 2GG

GSK Investigational Site, Cambridge

Sponsors

Lead Sponsor

GlaxoSmithKline
All Listed Sponsors
lead

GlaxoSmithKline

INDUSTRY

NCT01808482 - A First Time in Human Study Exploring Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK2618960 in Healthy Volunteers and Patients With Relapsing Remitting Multiple Sclerosis (RRMS) | Biotech Hunter | Biotech Hunter