Healthy VolunteersPhase 1NCT02452996
Safety Study of GNbAC1 Monoclonal Antibody in Healthy Male Volunteers
A Phase 1 study testing GNbAC1 in people with Healthy Volunteers, run by GeNeuro Innovation SAS at 1 site in Germany.
Trial summary
In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients will be evaluated in healthy male volunteers. 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
- Healthy Volunteers
- What is being tested?
- GNbAC1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2015to Aug 2015
- 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
- Healthy male subjects as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at Screening and confirmed at Day -1 who have signed the informed consent.
- Aged from 18 to 55 years, both inclusive.
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 that requires no treatment may be tolerated).
- Need of any prescription medication within 15 days prior to the administration of the study drug and/or non-prescription medication within 7 days prior to the administration of the study drug or anticipated need for any concomitant medication during the study.
- Participation in a clinical trial during the previous 3 months, i.e. from completion of the previous trial to the planned first administration of the current trial.
- NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients will be evaluated in healthy male volunteers.
Read the detailed description
The monoclonal antibody, GNbAC1, targets the envelope protein (Env) of the human endogenous retrovirus (HERV), also called multiple sclerosis associated retrovirus (MSRV), which is considered as a critical factor in the development of multiple sclerosis.
This study will assess the pharmacokinetics, safety and tolerability of GNbAC1 following single ascending doses (6, 18, and 36 mg/kg) administered via IV infusion.
- Conditions
- Healthy Volunteers
- Being tested
- GNbAC1
- Keywords
- GNbAC1, Multiple Sclerosis, Multiple Sclerosis Associated Retrovirus (MSRV), MSRV-Envelope protein, Monoclonal antibody, 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.
GNbAC1Drug
Single dose of IMP, IV infusion
| Study group | Role | What they receive |
|---|---|---|
| 6 mg/kg GNbAC1 | Active comparator | 7 subjects randomized 5:2 active treatment:placebo Receives: Drug: GNbAC1 |
| 18 mg/kg GNbAC1 | Active comparator | 7 subjects randomized 5:2 active treatment:placebo Receives: Drug: GNbAC1 |
| 36 mg/kg GNbAC1 | Active comparator | 7 subjects randomized 5:2 active treatment:placebo Receives: Drug: GNbAC1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects
AE, SAE, vital signs, ECG, clinical laboratory values
Measured: 57 days
Secondary outcomes (3)
PK characteristics: GNbAC1 serum concentrations
GNbAC1 serum concentrations over time
Measured: 57 days
immunogenicity in terms of antibodies against GNbAC1 (anti-drug antibodies)
antibodies against GNbAC1 (anti-drug antibodies)
Measured: 57 days
ratio of serum to CSF GNbAC1 concentration
GNbAC1 cerebrospinal fluid concentration at Day 2 and Weeks 2 and 4 after administration
Measured: 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study startApr 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 21 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GeNeuro Innovation SAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Georg Golor, MD, Principal investigator, Parexel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02452996
- Sponsor's protocol ID
- GNC-001bis
- Other IDs
- 2014-005113-23, 2014
- Status last verified
- Aug 2015
- First submitted
- 21 May 2015
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
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
- A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
- ClinicalTrials.gov ID
- NCT02452996
- Acronym / sponsor ID
- GNC-001bis
- Conditions
- Healthy Volunteers
- Keywords
- GNbAC1, Multiple Sclerosis, Multiple Sclerosis Associated Retrovirus (MSRV), MSRV-Envelope protein, Monoclonal antibody, Temelimab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (estimated)
- Lead sponsor
- GeNeuro Innovation SASIndustry (pharma, biotech, devices)
- Study start
- Apr 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 25 May 2015 (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.
In this clinical study, the safety and tolerability of GNbAC1 as a treatment for MS patients will be evaluated in healthy male volunteers.
Detailed description
The monoclonal antibody, GNbAC1, targets the envelope protein (Env) of the human endogenous retrovirus (HERV), also called multiple sclerosis associated retrovirus (MSRV), which is considered as a critical factor in the development of multiple sclerosis.
This study will assess the pharmacokinetics, safety and tolerability of GNbAC1 following single ascending doses (6, 18, and 36 mg/kg) administered via IV infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 6 mg/kg GNbAC1 | Active comparator | Drug: GNbAC17 subjects randomized 5:2 active treatment:placebo |
| 18 mg/kg GNbAC1 | Active comparator | Drug: GNbAC17 subjects randomized 5:2 active treatment:placebo |
| 36 mg/kg GNbAC1 | Active comparator | Drug: GNbAC17 subjects randomized 5:2 active treatment:placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy male subjects as determined by past medical history, physical examination, vital signs, ECG and laboratory tests at Screening and confirmed at Day -1 who have signed the informed consent.
- Aged from 18 to 55 years, both inclusive.
Key exclusion criteria (5 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 that requires no treatment may be tolerated).
- Need of any prescription medication within 15 days prior to the administration of the study drug and/or non-prescription medication within 7 days prior to the administration of the study drug or anticipated need for any concomitant medication during the study.
- Participation in a clinical trial during the previous 3 months, i.e. from completion of the previous trial to the planned first administration of the current trial.
- NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
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 of IMP, IV infusion | Drug | 18 mg/kg GNbAC1, 36 mg/kg GNbAC1, 6 mg/kg GNbAC1 |
Primary outcome
safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects
Time frame: 57 days
AE, SAE, vital signs, ECG, clinical laboratory values
3 secondary outcomes
PK characteristics: GNbAC1 serum concentrations
Time frame: 57 days
immunogenicity in terms of antibodies against GNbAC1 (anti-drug antibodies)
Time frame: 57 days
ratio of serum to CSF GNbAC1 concentration
Time frame: 29 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.
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Screening Protocol
Pain
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.
Georg Golor, MD principal investigator
Parexel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GNbAC1 in people with Healthy Volunteers, run by GeNeuro Innovation SAS at 1 site in Germany.
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 2 inclusion and 5 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.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
safety and tolerability of single ascending doses of GNbAC1 in healthy male subjects (time frame: 57 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.