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CompletedNCT03574428Updated Oct 20, 2020

Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

A Phase 1 interventional study of GNbAC1 and GNbAC1 Placebo in Multiple Sclerosis, sponsored by GeNeuro Australia PTY Ltd. Completed at 1 site in Australia. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-20.

Sponsored by GeNeuro Australia PTY Ltd · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Multiple Sclerosis

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Keywords

  • Temelimab
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 24 is below the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

GeNeuro Australia PTY Ltd is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
24 participants (actual)

Study arms

  • Active comparator
    Cohort 1

    GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo

    Drug: GNbAC1 · Other: GNbAC1 Placebo

  • Active comparator
    Cohort 2

    GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo

    Drug: GNbAC1 · Other: GNbAC1 Placebo

  • Active comparator
    Cohort 3

    GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo

    Drug: GNbAC1 · Other: GNbAC1 Placebo

  • Active comparator
    Cohort 4

    GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo

    Drug: GNbAC1 · Other: GNbAC1 Placebo

Interventions

  • DrugGNbAC1

    Monoclonal Antibody infused i.v.

  • OtherGNbAC1 Placebo

    Equivalent to GNbAC1 Buffer

06

What researchers measure

Primary outcomes

  1. Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)

    Serious Adverse Events (SAE), Adverse Events (AE)

    Time frame: 57 days

Secondary outcomes

  1. Pharmacokinetic (PK): GNbAC1 serum concentrations over time

    GNbAC1 serum concentrations over time

    Time frame: 57 days

  2. Immunogenicity: Antibodies against GNbAC1 (ADA)

    Antibodies against GNbAC1 (ADA)

    Time frame: 57 days

07

Study locations

1 site
  • Scientia Clinical Research Ltd
    Sydney, New South Wales 2031, Australia
08

References and documents

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. PubMed 31311668 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 20, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03574428
Lead sponsor
GeNeuro Australia PTY Ltd
Responsible party
Sponsor
First posted
Jul 2, 2018
Start date
May 8, 2018
Primary completion
Nov 2, 2018
Completion
Nov 2, 2018
Last update
Oct 20, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2019. You cannot join it, but the record below documents what was studied.

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