- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01424423
NOGO-A in Multiple Sclerosis FTIH
A Randomized, Single-blind (Investigator and Subject), Placebo-controlled, Single Ascending Dose Study Exploring the Preliminary Safety, Tolerability, and Pharmacokinetics of GSK1223249 Administered by Intravenous (IV) Infusion to Subjects With Relapsing Forms of Multiple Sclerosis, Not on Disease Modifying Therapy
The drug being tested in this study is GSK1223249. The drug works by inhibiting a protein that prevents nerve growth.
The trial is expected to involve approximately 36 patients. The study objective is to investigate the tolerability, safety and the way the body handles GSK1223249 after a range of single doses in patients with Multiple Sclerosis (MS).
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Victoria
-
Heidelberg, Victoria, Australia, VIC 3084
- GSK Investigational Site
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Suitable as determined by the Principal Investigator, based on his/her overall evaluation. A patient with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Diagnosed with a relapsing form of MS defined as either
- Relapsing Remitting MS according to revised McDonald Criteria [McDonald, 2001; Polman, 2005] plus any one of the following:
Occurrence of at least one relapse in the previous 12 months OR at least 2 relapses in the previous 24 months OR at least one documented Gd-enhancing lesion by magnetic resonance imaging (MRI) within 12 months prior to screening.
OR
-Secondary Progressive MS, plus any one of the following: Occurrence of at least one relapse in the previous 12 months OR at least 2 relapses in the previous 24 months OR at least one documented Gd-enhancing lesion by magnetic resonance imaging (MRI) within 12 months prior to screening.
- Expanded Disability Status Scale (EDSS) score ≤5.5
- Male or female between 18 and 55 years of age inclusive, at the time of signing the informed consent.
Exclusion Criteria:
- Abnormal baseline blood tests
- Treatment with interferon-beta-1b (Betaferon), interferon-beta-1a (Rebif or Avonex), or glatiramer acetate (Copaxone) within 90 days of dosing.
- Treatment with methylprednisolone or any other systemic steroids within 60 days of dosing.
- Treatment within the past 12 months or currently with any of the following agents: cyclosporine, azathioprine, methotrexate, cladribine, natalizumab (Tysabri®) or other monoclonal antibodies, murine protein, T-cell vaccination, plasmapheresis, IVI gG, ,stem cell transplantation.
- History of intolerance to acetominophen, ibuprofen, naproxen or any other non-steroidal anti-inflammatory agent which would preclude use of at least one of these during the study.
- Previous history of anaphylaxis, severe allergic reaction, or hypersensitivity to albumin or a protein-based therapeutic, including natalizumab (Tysabri) or any other monoclonal antibody. History of hypersensitivity to any of the components of the formulation.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result.
- Patients with evidence of dementia or psychiatric illness which, in the Investigator's opinion, is likely to prevent them from a full understanding of and/or compliance with the study requirements and procedures.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: SEQUENTIAL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Subjects receiving GSK1223249 in cohort 1
Eligible subjects will receive intravenous infusion of GSK1223249 with a starting dose of 0.02 milligrams per kilograms, followed by 0.2, 2, 10 and 30 milligrams per kilograms, administered by a programmable syringe pump.
|
I.V. Infusion
|
PLACEBO_COMPARATOR: Subjects receiving placebo in cohort 1
Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.
|
Placebo
|
EXPERIMENTAL: Subjects receiving GSK1223249 in cohort 2
Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 0.2 milligrams per kilograms administered by a programmable syringe pump.
|
I.V. Infusion
|
PLACEBO_COMPARATOR: Subjects receiving placebo in cohort 2
Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.
|
Placebo
|
EXPERIMENTAL: Subjects receiving GSK1223249 in cohort 3
Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 2 milligrams per kilograms administered by a programmable syringe pump.
|
I.V. Infusion
|
PLACEBO_COMPARATOR: Subjects receiving placebo in cohort 3
Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.
|
Placebo
|
EXPERIMENTAL: Subjects receiving GSK1223249 in cohort 4
Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 10 milligrams per kilograms administered by a programmable syringe pump.
|
I.V. Infusion
|
PLACEBO_COMPARATOR: Subjects receiving placebo in cohort 4
Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.
|
Placebo
|
EXPERIMENTAL: Subjects receiving GSK1223249 in cohort 5
Eligible subjects will receive intravenous infusion of GSK1223249 with a dose of 30 milligrams per kilograms administered by a programmable syringe pump.
|
I.V. Infusion
|
PLACEBO_COMPARATOR: Subjects receiving placebo in cohort 5
Eligible subjects will receive intravenous infusion of placebo, administered by a programmable syringe pump.
|
Placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The preliminary safety and tolerability of single doses of GSK1223249
Time Frame: screening, baseline (pre-dose) and up to 84 days post dose
|
changes in Vital signs, Electocardiogram, safety laboratory samples, adverse event (AE), neurological examination and MS relapses
|
screening, baseline (pre-dose) and up to 84 days post dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Single dose pharmacokinetics.
Time Frame: screening, baseline (pre-dose) and up to 84 days post dose
|
(AUC(0-∞)
|
screening, baseline (pre-dose) and up to 84 days post dose
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112988
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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