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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00622609




Registration number
NCT00622609
Ethics application status
Date submitted
13/02/2008
Date registered
25/02/2008

Titles & IDs
Public title
Anti-MAG First Administration to Human
Scientific 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
Secondary ID [1] 0 0
MAG103114
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cerebrovascular Accident 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GSK249320A
Treatment: Drugs - Placebo

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.

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.


Treatment: Drugs: GSK249320A
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.

Treatment: Drugs: Placebo
Sodium chloride intravenous infusion will be given as matching placebo.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Throughout study
Secondary outcome [1] 0 0
Pharmacokinetic parametersAnti-GSK249320 antibody titres
Timepoint [1] 0 0
At various timepoints from pre-dose to Week 52 follow-up
Secondary outcome [2] 0 0
Pharmacokinetic parameters of ascending single IV doses of GSK249320: Cinf, AUC(0-24), AUC(0-t) and AUC(0-inf)
Timepoint [2] 0 0
At various timepoints from pre-dose to Week 52 follow-up
Secondary outcome [3] 0 0
Anti-GSK249320 Antibody titres: serum samples will be collected for anti-drug (anti-GSK249320) antibody confirmation, titration and neutralization testing
Timepoint [3] 0 0
At various timepoints from pre-dose to Week 52 follow-up
Secondary outcome [4] 0 0
Non-compartmental pharmacokinetic parameters of GSK249320 : Tinf , lz, T1/2, CL and Vss
Timepoint [4] 0 0
At various timepoints from pre-dose to Week 52 follow-up
Secondary outcome [5] 0 0
Novel candidate biomarkers and subsequently discovered biomarkers of the biological response associated with the action of GSK249320 may be identified by application of:
Timepoint [5] 0 0
At various timepoints from pre-dose to Week 52 follow-up
Secondary outcome [6] 0 0
RNA transcriptome analysis of blood samples
Timepoint [6] 0 0
At various timepoints from pre-dose to Week 52 follow-up
Secondary outcome [7] 0 0
Proteome analysis of plasma samples
Timepoint [7] 0 0
At various timepoints from pre-dose to Week 52 follow-up

Eligibility
Key inclusion criteria
* 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.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
* 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.
* 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/08/2007
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
9/04/2009
Sample size
Target
Accrual to date
Final
46
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
GSK Investigational Site - Randwick, Sydney
Recruitment postcode(s) [1] 0 0
2031 - Randwick, Sydney
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Maryland

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GlaxoSmithKline
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
GSK Clinical Trials
Address 0 0
GlaxoSmithKline
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT00622609