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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03574428 |
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Date of registration:
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16/05/2018 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
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Scientific title:
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A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers |
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Date of first enrolment:
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May 8, 2018 |
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Target sample size:
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24 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03574428 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 1
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Countries of recruitment
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Australia
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Key inclusion & exclusion criteria
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Main Inclusion Criteria:
- Healthy male volunteers
- Negative urine drug screen
- Have signed the informed consent.
Main Exclusion Criteria:
- History of serious adverse reactions or hypersensitivity to any drug.
- Use of any prescription medication within 30 days prior to the administration of
investigational product and/or non-prescription medication (including herbal and
natural remedies, homeopathy, vitamins, and minerals) within 7 days prior to the
administration of investigational product or anticipated use of any concomitant
medication during the study. Permissible exceptions are paracetamol up to 4g/day
ceasing a minimum of 12 hours prior to infusion and Ibuprofen up to 1.2g/day ceasing a
minimum of 24 hours prior to infusion. Paracetamol and ibuprofen are allowed during
the study, but only 24 hours after completion of the administration of investigational
product.
Age minimum:
18 Years
Age maximum:
55 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Multiple Sclerosis
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Intervention(s)
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Drug: GNbAC1
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Other: GNbAC1 Placebo
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Primary Outcome(s)
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Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)
[Time Frame: 57 days]
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Secondary Outcome(s)
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Immunogenicity: Antibodies against GNbAC1 (ADA)
[Time Frame: 57 days]
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Pharmacokinetic (PK): GNbAC1 serum concentrations over time
[Time Frame: 57 days]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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