- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01699555
First-in-Human Study With GNbAC1 in Healthy Volunteers
October 19, 2020 updated by: GeNeuro Innovation SAS
Randomized Placebo-Controlled First-in-Human Study With GNbAC1
The purpose of this study is to assess the safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Scientific research has shown that the expression of genes of a virus which is integrated in the Human genetic material, the Multiple Sclerosis associated RetroVirus (MSRV) could play a critical role in the causation of multiple sclerosis.
GNbAC1 is an experimental medication, which neutralizes (i.e.
inactivates) a protein of MSRV that might contribute to the development or deterioration of multiple sclerosis.
Study Type
Interventional
Enrollment (Actual)
33
Phase
- Phase 1
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Male healthy subjects, 18-55 years of age and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram and laboratory tests at Screening and confirmed at baseline.
- Clinically acceptable for the purposes of the study sitting blood pressure and pulse rate, i.e.: BP: 100 - 150 mm Hg systolic, 50 - 95 mm Hg diastolic and pulse rate: 45 - 100 bpm. Blood pressure and pulse will be measured after 3 minutes resting in a sitting position.
- Body mass index between 18.5 and 30.0 kg/m2 and body weight in the 50 - 95 kg range.
- No need for regular concomitant medication
- Subjects with partners of childbearing potential have to use adequate contraception during, and for at least the four weeks after administration of study medication. Adequate contraception is defined as usage by at least one of the partners of a barrier method of contraception, together with usage by the female partner, commencing at least three months prior to Screening, of a stable regimen of any form of hormonal contraception or an intra-uterine device. Use of abstinence alone is not considered adequate. Use of a barrier method alone is considered adequate only if the subject was vasectomized at least six months prior to Screening.
- Ability to communicate well with the investigator and comply with the requirements of the entire study.
- The subject has given written consent to participate in the study.
Exclusion Criteria:
- History of serious adverse reactions or hypersensitivity to any drug.
- Presence or history of any allergy requiring acute or chronic treatment (seasonal allergic rhinitis which requires no treatment may be tolerated).
- Abnormal physical findings of clinical significance at the Screening or baseline examination which would interfere with the objectives of the study.
- Need of any prescription medication within 30 days prior to the administration of the drug and/or nonprescription medication within 7 days prior to the administration of the drug or anticipated need for any concomitant medication during the study.
- Participation in a clinical trial during the previous 4 weeks, i.e. from completion of the previous trial to the planned first administration of the current trial.
- Loss of 500 mL blood or more during the 3 month period before the screening visit of the study, e.g. as a donor.
- Existence of any surgical or medical condition which might relevantly interfere with the subject safety, the distribution, metabolism or excretion of the drug or the study assessments, i.e. impaired renal or hepatic function, diabetes mellitus, cardiovascular abnormalities, chronic symptoms of pronounced constipation or diarrhea or conditions associated with total or partial obstruction of the urinary tract.
- Symptoms of a significant (upon Investigator's medical judgment) somatic or mental illness in the two week period preceding drug administration.
- History or clinical evidence of significant cardiovascular, respiratory, renal, hepatic,gastrointestinal, hematological, neurologic or other disease.
- History of hepatitis B and / or C and / or positive serology results which indicate the presence of hepatitis B and / or C.
- Positive results from the HIV serology.
- Positive for MSRV env by RNA PCR
- Clinically significant abnormal laboratory values (as determined by the Principal Investigator in consultation with the sponsor) at the Screening or baseline evaluation.
- History of serious mental disorders.
- History of alcohol or drug abuse in the last 3 years.
- Heavy smokers, i.e. more than 10 cigarettes per day and/or unwillingness to refrain from smoking during the entire in-house period.
- Positive results of the drug Screening.
- Need for a vaccination from Screening to End of Study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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
|
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
|
PLACEBO_COMPARATOR: GNbAC1 placebo
Single dose intravenous (IV) GNbAC1 placebo
|
Single dose intravenous (IV) GNbAC1 placebo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of reported adverse events for healthy male subjects receiving single ascending doses of GNbAC1.
Time Frame: 64 days
|
the number of adverse events along with the results of physical examinations, ECG and clinical laboratory tests will be used to determine the safety profile of GNbAC1.
|
64 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pharmacokinetics (PK) characteristics following administration of single ascending doses of GNbAC1 in healthy male subjects
Time Frame: 64 days
|
the following parameters will be determined: serum concentrations of GNbAC1 and the derived PK parameters AUC0-inf, AUC0-tlast, %AUC, Cmax, tmax, t1/2, λz, CL, Vss, Vz, MRT.
|
64 days
|
immunogenicity of GNbAC1
Time Frame: 64 days
|
64 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Thierry Kamtchoua, M.D, Covance Clinical Research Unit AG
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (ACTUAL)
March 1, 2012
Study Completion (ACTUAL)
August 1, 2012
Study Registration Dates
First Submitted
September 27, 2012
First Submitted That Met QC Criteria
October 1, 2012
First Posted (ESTIMATE)
October 3, 2012
Study Record Updates
Last Update Posted (ACTUAL)
October 20, 2020
Last Update Submitted That Met QC Criteria
October 19, 2020
Last Verified
December 1, 2012
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GNC-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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