Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-08

Study Completion Date

2018-11-02

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers

NCT02452996

Healthy Volunteers

COMPLETED PHASE1

First-in-Human Study With GNbAC1 in Healthy Volunteers

NCT01699555

Multiple Sclerosis

COMPLETED PHASE1

Safety Study of GNbAC1 in Multiple Sclerosis Patients

NCT01639300

Multiple Sclerosis

COMPLETED PHASE2

Assessment of Repeat Ascending Doses of GSK2018682 in Healthy Volunteers

NCT01431937

Multiple Sclerosis, Relapsing-Remitting

COMPLETED PHASE1

A Single Ascending Dose Study of GZ402668 in Patients With Progressive Multiple Sclerosis

NCT02977533

Progressive Multiple Sclerosis

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multiple Sclerosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort 1

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

Group Type ACTIVE_COMPARATOR

GNbAC1

Intervention Type DRUG

Monoclonal Antibody infused i.v.

GNbAC1 Placebo

Intervention Type OTHER

Equivalent to GNbAC1 Buffer

Cohort 2

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

Group Type ACTIVE_COMPARATOR

GNbAC1

Intervention Type DRUG

Monoclonal Antibody infused i.v.

GNbAC1 Placebo

Intervention Type OTHER

Equivalent to GNbAC1 Buffer

Cohort 3

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

Group Type ACTIVE_COMPARATOR

GNbAC1

Intervention Type DRUG

Monoclonal Antibody infused i.v.

GNbAC1 Placebo

Intervention Type OTHER

Equivalent to GNbAC1 Buffer

Cohort 4

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

Group Type ACTIVE_COMPARATOR

GNbAC1

Intervention Type DRUG

Monoclonal Antibody infused i.v.

GNbAC1 Placebo

Intervention Type OTHER

Equivalent to GNbAC1 Buffer

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GNbAC1

Monoclonal Antibody infused i.v.

Intervention Type DRUG

GNbAC1 Placebo

Equivalent to GNbAC1 Buffer

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes