Multiple SclerosisPhase 1NCT01699555
First-in-Human Study With GNbAC1 in Healthy Volunteers
A Phase 1 study testing GNbAC1 in people with Multiple Sclerosis, run by GeNeuro Innovation SAS.
Trial summary
The purpose of this study is to assess the safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- GNbAC1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- No sites listed yet
- Study dates
- Jul 2011to Aug 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- GNbAC1, GNbAC1 placebo
- Keywords
- Multiple sclerosis, GNbAC1, Monoclonal antibody, Multiple Sclerosis Associated Retrovirus (MSRV), Temelimab
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GNbAC1Biological
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
GNbAC1 placeboBiological
Single dose intravenous (IV) GNbAC1 placebo
| Study group | Role | What they receive |
|---|---|---|
| GNbAC1 | Experimental | 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 Receives: Biological: GNbAC1 |
| GNbAC1 placebo | Placebo comparator | Single dose intravenous (IV) GNbAC1 placebo Receives: Biological: GNbAC1 placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of reported adverse events for healthy male subjects receiving single ascending doses of GNbAC1.
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.
Measured: 64 days
Secondary outcomes (2)
pharmacokinetics (PK) characteristics following administration of single ascending doses of GNbAC1 in healthy male subjects
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.
Measured: 64 days
immunogenicity of GNbAC1
Measured: 64 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2012 (estimated)
- Study startJul 2011
- Primary completionMar 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeNeuro Innovation SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thierry Kamtchoua, M.D, Principal investigator, Covance Clinical Research Unit AG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01699555
- Sponsor's protocol ID
- GNC-001
- Status last verified
- Dec 2012
- First submitted
- 27 Sep 2012
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Curtin F, Lang AB, Perron H, Laumonier M, Vidal V, Porchet HC, Hartung HP. GNbAC1, a humanized monoclonal antibody against the envelope protein of multiple sclerosis-associated endogenous retrovirus: a first-in-humans randomized clinical study. Clin Ther. 2012 Dec;34(12):2268-78. doi: 10.1016/j.clinthera.2012.11.006. Epub 2012 Nov 29.
PubMed 23200102
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Placebo-Controlled First-in-Human Study With GNbAC1
- ClinicalTrials.gov ID
- NCT01699555
- Acronym / sponsor ID
- GNC-001
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis, GNbAC1, Monoclonal antibody, Multiple Sclerosis Associated Retrovirus (MSRV), Temelimab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- GeNeuro Innovation SASIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- Mar 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 3 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GNbAC1 | Experimental | Biological: GNbAC1Single dose intravenous (IV) GNbAC1 of 0.0025mg/kg, 0.025mg/kg, 0.15mg/kg, 0.60mg/kg, 2.00mg/kg or 6.00mg/kg |
| GNbAC1 placebo | Placebo comparator | Biological: GNbAC1 placeboSingle dose intravenous (IV) GNbAC1 placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GNbAC1Single 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 |
| GNbAC1 placeboSingle dose intravenous (IV) GNbAC1 placebo | Biological | GNbAC1 placebo |
Primary outcome
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.
2 secondary outcomes
pharmacokinetics (PK) characteristics following administration of single ascending doses of GNbAC1 in healthy male subjects
Time frame: 64 days
immunogenicity of GNbAC1
Time frame: 64 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2020.
- Results publication: PubMed 23200102Curtin F, Lang AB, Perron H, Laumonier M, Vidal V, Porchet HC, Hartung HP. GNbAC1, a humanized monoclonal antibody against the envelope protein of multiple sclerosis-associated endogenous retrovirus: a first-in-humans randomized clinical study. Clin Ther. 2012 Dec;34(12):2268-78. doi: 10.1016/j.clinthera.2012.11.006. Epub 2012 Nov 29.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Thierry Kamtchoua, M.D principal investigator
Covance Clinical Research Unit AG
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GNbAC1 in people with Multiple Sclerosis, run by GeNeuro Innovation SAS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of reported adverse events for healthy male subjects receiving single ascending doses of GNbAC1. (time frame: 64 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01699555, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2020.