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Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers

NCT03574428 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-10-20

No results posted yet for this 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.

Conditions

Interventions

DRUG

GNbAC1

Monoclonal Antibody infused i.v.

OTHER

GNbAC1 Placebo

Equivalent to GNbAC1 Buffer

Sponsors & Collaborators

  • GeNeuro Australia PTY Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-08
Primary Completion
2018-11-02
Completion
2018-11-02

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03574428 on ClinicalTrials.gov