Anti-MAG First Administration to Human

Completed

Phase 1 Results N/A

Trial Description

GSK249320 is a monoclonal antibody directed against myelin associated glycoprotein (MAG), a protein that inhibits axonal regeneration. GSK249320 acts as a MAG antagonist, and through this activity it is hypothesised that it will enhance recovery from neuronal degeneration following acute axonal injury, which occurs in spinal cord injury or stroke.

Conditions

Interventions

  • Placebo Drug
    Intervention Desc: Sodium chloride intravenous infusion will be given as matching placebo.
    ARM 1: Kind: Experimental
    Label: Placebo
    ARM 2: Kind: Experimental
    Label: Subjects receiving placebo
    Description: Eligible subjects will receive single dose of sodium chloride in cohort 1 to 6, administered as a slow intravenous infusion over 1 hour on Day 1.
  • GSK249320 Drug
    Intervention Desc: IV Infusion
    ARM 1: Kind: Experimental
    Label: GSK249320
  • GSK249320A Drug
    Intervention Desc: GSK249320A intravenous infusion will be formulated as 100 milligrams/milliliters in 2 milliliters vials (filled to 1 milliliter), in phosphate buffer and delivered by a syringe and programmable pump.
    ARM 1: Kind: Experimental
    Label: Subjects receiving GSK249320A
    Description: Eligible subjects will receive escalating doses of GSK249320A in cohort 1 to 6 with a starting dose of 0.04 milligrams/kilograms up to the maximum dose of 25 milligrams/kilograms, administered as a slow intravenous infusion over 1 hour on Day 1.

Trial Design

  • Allocation: Randomized
  • Masking: Single Blind (Subject)
  • Purpose: Treatment
  • Endpoint: Safety Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Safety and tolerability of GSK249320 including: adverse events,vital signs,ECG,continuous lead II ECG monitoring,safety laboratory assessments,clinical assessment of peripheral nerve function,nerve conduction testing Throughout study No
Secondary Pharmacokinetic parametersAnti-GSK249320 antibody titres At various timepoints from pre-dose to Week 52 follow-up No
Secondary Pharmacokinetic parameters of ascending single IV doses of GSK249320: Cinf, AUC(0-24), AUC(0-t) and AUC(0-inf) At various timepoints from pre-dose to Week 52 follow-up No
Secondary Anti-GSK249320 Antibody titres: serum samples will be collected for anti-drug (anti-GSK249320) antibody confirmation, titration and neutralization testing At various timepoints from pre-dose to Week 52 follow-up No
Secondary Non-compartmental pharmacokinetic parameters of GSK249320 : Tinf , lz, T1/2, CL and Vss At various timepoints from pre-dose to Week 52 follow-up No
Secondary Novel candidate biomarkers and subsequently discovered biomarkers of the biological response associated with the action of GSK249320 may be identified by application of: At various timepoints from pre-dose to Week 52 follow-up No
Secondary RNA transcriptome analysis of blood samples At various timepoints from pre-dose to Week 52 follow-up No
Secondary Proteome analysis of plasma samples At various timepoints from pre-dose to Week 52 follow-up No

Sponsors