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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03574428




Registration number
NCT03574428
Ethics application status
Date submitted
16/05/2018
Date registered
2/07/2018
Date last updated
20/10/2020

Titles & IDs
Public title
Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Scientific title
A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
Secondary ID [1] 0 0
GNC-006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - GNbAC1
Other interventions - GNbAC1 Placebo

Active comparator: Cohort 1 - GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo

Active comparator: Cohort 2 - GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo

Active comparator: Cohort 3 - GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo

Active comparator: Cohort 4 - GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo


Treatment: Drugs: GNbAC1
Monoclonal Antibody infused i.v.

Other interventions: GNbAC1 Placebo
Equivalent to GNbAC1 Buffer
Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)
Timepoint [1] 0 0
57 days
Secondary outcome [1] 0 0
Pharmacokinetic (PK): GNbAC1 serum concentrations over time
Timepoint [1] 0 0
57 days
Secondary outcome [2] 0 0
Immunogenicity: Antibodies against GNbAC1 (ADA)
Timepoint [2] 0 0
57 days

Eligibility
Key inclusion criteria
Main

* Healthy male volunteers
* Negative urine drug screen
* Have signed the informed consent.

Main
Minimum age
18 Years
Maximum age
55 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key 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.

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
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
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
8/05/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
2/11/2018
Sample size
Target
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Scientia Clinical Research Ltd - Sydney
Recruitment postcode(s) [1] 0 0
2031 - Sydney

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
GeNeuro Australia PTY Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This is a phase I, double-blind, placebo controlled, parallel group, dose-escalating, randomised study designed to assess and compare the safety and tolerability, PK, and immunogenicity of GNbAC1 administered as a single dose at 4 different dose levels of 36, 60, 85 and 110 mg/kg.
Trial website
https://clinicaltrials.gov/study/NCT03574428
Trial related presentations / publications
Porchet H, Vidal V, Kornmann G, Malpass S, Curtin F. A High-dose Pharmacokinetic Study of a New IgG4 Monoclonal Antibody Temelimab/GNbAC1 Antagonist of an Endogenous Retroviral Protein pHERV-W Env. Clin Ther. 2019 Sep;41(9):1737-1746. doi: 10.1016/j.clinthera.2019.05.020. Epub 2019 Jul 13.
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03574428