Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

NCT03574428 | Completed Phase 1

• 1 other identifier: GNC-006
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Keywords

Temelimab

Outcome Measures

Primary Outcomes (1)

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

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

  57 days

Secondary Outcomes (2)

• Pharmacokinetic (PK): GNbAC1 serum concentrations over time

  57 days

• Immunogenicity: Antibodies against GNbAC1 (ADA)

  57 days

Study Arms (4)

Cohort 1

ACTIVE COMPARATOR

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

Drug: GNbAC1; Other: GNbAC1 Placebo

Cohort 2

ACTIVE COMPARATOR

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

Drug: GNbAC1; Other: GNbAC1 Placebo

Cohort 3

ACTIVE COMPARATOR

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

Drug: GNbAC1; Other: GNbAC1 Placebo

Cohort 4

ACTIVE COMPARATOR

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

Drug: GNbAC1; Other: GNbAC1 Placebo

Interventions

GNbAC1 DRUG

Monoclonal Antibody infused i.v.

Cohort 1; Cohort 2; Cohort 3; Cohort 4

GNbAC1 Placebo OTHER

Equivalent to GNbAC1 Buffer

Cohort 1; Cohort 2; Cohort 3; Cohort 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• GeNeuro Australia PTY Ltd: lead

Study Sites (1)

Scientia Clinical Research Ltd

Sydney, New South Wales, 2031, Australia

Location

Related Publications (1)

• 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.

  PMID: 31311668 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

temelimab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: July 2, 2018
• Study Start: May 8, 2018
• Primary Completion: November 2, 2018
• Study Completion: November 2, 2018
• Last Updated: October 20, 2020

Record last verified: 2019-05

Locations

AU (1)