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First-in-Human Study With GNbAC1 in Healthy Volunteers

NCT01699555 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2020-10-20

No results posted yet for this study

Summary

The purpose of this study is to assess the safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects.

Conditions

Interventions

BIOLOGICAL

GNbAC1

Single dose intravenous (IV) GNbAC1 of 0.0025mg/kg, 0.025mg/kg, 0.15mg/kg, 0.60mg/kg, 2.00mg/kg or 6.00mg/kg

BIOLOGICAL

GNbAC1 placebo

Single dose intravenous (IV) GNbAC1 placebo

Sponsors & Collaborators

  • GeNeuro Innovation SAS

    lead INDUSTRY

Principal Investigators

  • Thierry Kamtchoua, M.D · Covance Clinical Research Unit AG

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2012-03-31
Completion
2012-08-31

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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 NCT01699555 on ClinicalTrials.gov