Anti-MAG First Administration to Human
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|ClinicalTrials.gov Identifier: NCT00622609|
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : July 21, 2017
|Condition or disease||Intervention/treatment||Phase|
|Cerebrovascular Accident||Drug: GSK249320A Drug: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Single-blind, Single Dose, Placebo Controlled, First Time in Human Study to Assess the Safety, Tolerability and Pharmacokinetics of Ascending Doses of GSK249320 in Healthy Volunteers|
|Actual Study Start Date :||August 1, 2007|
|Actual Primary Completion Date :||April 9, 2009|
|Actual Study Completion Date :||April 9, 2009|
Experimental: Subjects receiving GSK249320A
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.
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.
Placebo Comparator: Subjects receiving placebo
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.
Sodium chloride intravenous infusion will be given as matching placebo.
- 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 [ Time Frame: Throughout study ]
- Pharmacokinetic parametersAnti-GSK249320 antibody titres [ Time Frame: At various timepoints from pre-dose to Week 52 follow-up ]
- Pharmacokinetic parameters of ascending single IV doses of GSK249320: Cinf, AUC(0-24), AUC(0-t) and AUC(0-inf) [ Time Frame: At various timepoints from pre-dose to Week 52 follow-up ]
- Anti-GSK249320 Antibody titres: serum samples will be collected for anti-drug (anti-GSK249320) antibody confirmation, titration and neutralization testing [ Time Frame: At various timepoints from pre-dose to Week 52 follow-up ]
- Non-compartmental pharmacokinetic parameters of GSK249320 : Tinf , lz, T1/2, CL and Vss [ Time Frame: At various timepoints from pre-dose to Week 52 follow-up ]
- Novel candidate biomarkers and subsequently discovered biomarkers of the biological response associated with the action of GSK249320 may be identified by application of: [ Time Frame: At various timepoints from pre-dose to Week 52 follow-up ]
- RNA transcriptome analysis of blood samples [ Time Frame: At various timepoints from pre-dose to Week 52 follow-up ]
- Proteome analysis of plasma samples [ Time Frame: At various timepoints from pre-dose to Week 52 follow-up ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00622609
|United States, Maryland|
|GSK Investigational Site|
|Baltimore, Maryland, United States, 21225|
|Australia, New South Wales|
|GSK Investigational Site|
|Randwick, Sydney, New South Wales, Australia, 2031|
|Study Director:||GSK Clinical Trials||GlaxoSmithKline|