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Cerebrovascular AccidentPhase 1NCT00622609

Anti-MAG First Administration to Human

A Phase 1 study testing GSK249320A in people with Cerebrovascular Accident, run by GlaxoSmithKline at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Cerebrovascular Accident
What is being tested?
GSK249320A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
46 participants
Where
2 sitesin 2 countries
Study dates
1 Aug 2007to 9 Apr 2009
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy adult men or women of non-child bearing potential (i.e. post-menopausal or surgically sterile e.g. hysterectomy or bilateral oophorectomy). If necessary, postmenopausal status will be confirmed by serum FSH and oestradiol concentrations at screening. Surgical sterility will be defined as females who have had a documented hysterectomy or bilateral oophorectomy.
  • Between 18 and 60 years of age inclusive.
  • Body weight >/ 60 kg and BMI within the range 19-29.9 kg/m2 inclusive.
  • Healthy as judged by responsible physician with no clinically significant abnormality identified on the medical or laboratory evaluation. A subject with a clinical abnormality or laboratory parameters outside the reference range for this age group may be included only if the Investigator considers that the finding will not introduce additional risk factors and will not interfere with the study procedures.
  • A 12-lead ECG at pre-study screening which in the opinion of the Investigator or his/her designee has no abnormalities that will compromise safety in this study.
  • Normal clinical neurological exam, normal QST results, and normal pattern of conduction latencies in medial, ulnar, sural, tibial and peroneal nerves at screening.
  • Signed and dated written informed consent prior to admission to the study.
  • The subject is able to understand and comply with protocol requirements, instructions and protocol-stated restrictions.

Who cannot join

  • Positive drug/ alcohol screen at screening or baseline.
  • Positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result at screening.
  • History of acute neuronal injury (central or peripheral) within the previous 12 months, peripheral neuropathy or neuritis, neurodegenerative disorders or other neurological diseases, including conditions which are known or hypothesised to be associated with disruption in the blood-brain barrier (BBB).
  • Considered to be at a high risk of developing a stroke including a history of carotid artery disease or surgery, transient ischaemic attacks, reversible ischaemic neurological deficits or other abnormalities of the brain vessels, including but not limited to berry aneurysms or arteriovenous malformations.
  • History of regular alcohol consumption averaging >7 drinks/week for women or >14 drinks/week for men. One drink is equivalent to (12 g alcohol) = 5 ounces (150 mL) of wine or 12 ounces (360 mL) of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.
  • Subjects who smoke 10 or more cigarettes per day. Subjects who smoke <10 cigarettes per day may be admitted into the study but will be asked to refrain from smoking for at least 24 hours before the planned day of admission into the unit. They will NOT be allowed to smoke during their stay in the unit.
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  • The subject is unable to abstain from strenuous physical activity for 72 h prior to each clinic visit where safety lab tests are conducted.
  • The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
  • Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period.
  • Previous exposure to humanised antibody therapy for any reason.
  • Unwillingness of the male subjects to abstain from sexual intercourse with pregnant or lactating women from the time of the first dose of study medication until five half lives following administration of the dose of study medication. This may be increased depending on PK analysis during the study.
  • Unwillingness of the male subject to use a condom/spermicide in addition to having their female partner use another form of contraception such as an intra-uterine device (IUD), diaphragm with spermicide, oral contraceptives, injectable progesterone, subdermal implants or a tubal ligation if the woman could become pregnant from the time of the first dose of study medication until five half lives following administration of the last dose of study medication. The duration of the period during which contraception must be practiced may be modified during the study, depending on data emerging from PK analysis. The mean half-life predicted for GSK249320 is 30 days
  • Female subjects with positive urine/serum pregnancy test result at screening or prior to first dose
  • Status as a "vulnerable" subject, defined by the US Food and Drug Administration (FDA) Code of Federal Regulations; 45 CFR, Section 46, Subparts B and C.

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • GSK Investigational Site

    Baltimore, Maryland, 21225

Other trials in United States

Australia1 site

  • GSK Investigational Site

    Randwick, Sydney, New South Wales, 2031

Other trials in Australia

About this study

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

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.

Being tested
GSK249320A, Placebo
Keywords
first time in human,, MAG, monoclonal antibody,, healthy subjects,, GSK249320,
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK249320ADrug

    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.

  • PlaceboDrug

    Sodium chloride intravenous infusion will be given as matching placebo.

Study groups in NCT00622609
Study groupRoleWhat they receive
Subjects receiving GSK249320AExperimentalEligible 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.
Receives: Drug: GSK249320A
Subjects receiving placeboPlacebo comparatorEligible 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.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: Throughout study

Secondary outcomes (7)

  1. Pharmacokinetic parametersAnti-GSK249320 antibody titres

    Measured: At various timepoints from pre-dose to Week 52 follow-up

  2. Pharmacokinetic parameters of ascending single IV doses of GSK249320: Cinf, AUC(0-24), AUC(0-t) and AUC(0-inf)

    Measured: At various timepoints from pre-dose to Week 52 follow-up

  3. Anti-GSK249320 Antibody titres: serum samples will be collected for anti-drug (anti-GSK249320) antibody confirmation, titration and neutralization testing

    Measured: At various timepoints from pre-dose to Week 52 follow-up

  4. Non-compartmental pharmacokinetic parameters of GSK249320 : Tinf , lz, T1/2, CL and Vss

    Measured: At various timepoints from pre-dose to Week 52 follow-up

  5. Novel candidate biomarkers and subsequently discovered biomarkers of the biological response associated with the action of GSK249320 may be identified by application of:

    Measured: At various timepoints from pre-dose to Week 52 follow-up

  6. RNA transcriptome analysis of blood samples

    Measured: At various timepoints from pre-dose to Week 52 follow-up

  7. Proteome analysis of plasma samples

    Measured: At various timepoints from pre-dose to Week 52 follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2008 (estimated)
  2. Study start1 Aug 2007
  3. Primary completion9 Apr 2009
  4. Study completion9 Apr 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00622609
Sponsor's protocol ID
MAG103114
Status last verified
Jul 2017
First submitted
13 Feb 2008
Last updated
21 Jul 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

  • Abila B, Cunningham E, Simeoni M. First-time-in-human study with GSK249320, a myelin-associated glycoprotein inhibitor, in healthy volunteers. Clin Pharmacol Ther. 2013 Feb;93(2):163-9. doi: 10.1038/clpt.2012.227. Epub 2012 Nov 16.

    PubMed 23267856

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK249320A in people with Cerebrovascular Accident, run by GlaxoSmithKline at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00622609, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.

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Anti-MAG First Administration to Human (NCT00622609) | AzTrials