Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

GeNeuro

Status and phase: Completed; Phase 1

Conditions: Multiple Sclerosis

Treatments: Other: GNbAC1 Placebo; Drug: GNbAC1

Study type: Interventional

Funder types: Industry

Identifiers

NCT03574428

GNC-006

Details and patient eligibility

About

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.

Enrollment: 24 patients

Sex: Male

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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24 participants in 4 patient groups

Cohort 1

Active Comparator group

Description:

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

Treatment:

Other: GNbAC1 Placebo

Drug: GNbAC1

Cohort 2

Active Comparator group

Description:

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

Treatment:

Other: GNbAC1 Placebo

Drug: GNbAC1

Cohort 3

Active Comparator group

Description:

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

Treatment:

Other: GNbAC1 Placebo

Drug: GNbAC1

Cohort 4

Active Comparator group

Description:

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

Treatment:

Other: GNbAC1 Placebo

Drug: GNbAC1