Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03574428

Enrollment

Registered

2018-07-02

Start date

2018-05-08

Completion date

2018-11-02

Last updated

2020-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

Temelimab

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.

Interventions

DRUGGNbAC1

Monoclonal Antibody infused i.v.

OTHERGNbAC1 Placebo

Equivalent to GNbAC1 Buffer

Study design

Allocation

RANDOMIZED

Intervention model

SEQUENTIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

MALE

Age

18 Years to 55 Years

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)	57 days	Serious Adverse Events (SAE), Adverse Events (AE)

Secondary

Measure	Time frame	Description
Pharmacokinetic (PK): GNbAC1 serum concentrations over time	57 days	GNbAC1 serum concentrations over time
Immunogenicity: Antibodies against GNbAC1 (ADA)	57 days	Antibodies against GNbAC1 (ADA)

Countries

Australia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 2, 2026