Multiple SclerosisPhase 1NCT03574428
Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
A Phase 1 study testing GNbAC1 in people with Multiple Sclerosis, run by GeNeuro Australia PTY Ltd at 1 site in Australia.
Trial 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. 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
- 24 participants
- Where
- 1 siteAustralia
- Study dates
- 8 May 2018to 2 Nov 2018
- 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
Main Inclusion Criteria:
- Healthy male volunteers
- Negative urine drug screen
- Have signed the informed consent.
Main Exclusion Criteria:
- History of serious adverse reactions or hypersensitivity to any drug.
- Use of any prescription medication within 30 days prior to the administration of investigational product and/or non-prescription medication (including herbal and natural remedies, homeopathy, vitamins, and minerals) within 7 days prior to the administration of investigational product or anticipated use of any concomitant medication during the study. Permissible exceptions are paracetamol up to 4g/day ceasing a minimum of 12 hours prior to infusion and Ibuprofen up to 1.2g/day ceasing a minimum of 24 hours prior to infusion. Paracetamol and ibuprofen are allowed during the study, but only 24 hours after completion of the administration of investigational product.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Scientia Clinical Research Ltd
Sydney, New South Wales, 2031
About this study
Official title: A Randomised, Double-Blind, Placebo Controlled, Single Ascending Doses Study With GNbAC1 in Healthy Male Volunteers
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
- Multiple Sclerosis
- Being tested
- GNbAC1, GNbAC1 Placebo
- Keywords
- 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
Monoclonal Antibody infused i.v.
GNbAC1 PlaceboOther
Equivalent to GNbAC1 Buffer
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 | Active comparator | GNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo Receives: Drug: GNbAC1; Other: GNbAC1 Placebo |
| Cohort 2 | Active comparator | GNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo Receives: Drug: GNbAC1; Other: GNbAC1 Placebo |
| Cohort 3 | Active comparator | GNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo Receives: Drug: GNbAC1; Other: GNbAC1 Placebo |
| Cohort 4 | Active comparator | GNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo Receives: Drug: GNbAC1; Other: GNbAC1 Placebo |
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 (Serious Adverse Events, Adverse Events)
Serious Adverse Events (SAE), Adverse Events (AE)
Measured: 57 days
Secondary outcomes (2)
Pharmacokinetic (PK): GNbAC1 serum concentrations over time
GNbAC1 serum concentrations over time
Measured: 57 days
Immunogenicity: Antibodies against GNbAC1 (ADA)
Antibodies against GNbAC1 (ADA)
Measured: 57 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2018
- Study start8 May 2018
- Primary completion2 Nov 2018
- Study completion2 Nov 2018
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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- GeNeuro Australia PTY Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03574428
- Sponsor's protocol ID
- GNC-006
- Status last verified
- May 2019
- First submitted
- 16 May 2018
- Last updated
- 20 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Porchet H, Vidal V, Kornmann G, Malpass S, Curtin F. A High-dose Pharmacokinetic Study of a New IgG4 Monoclonal Antibody Temelimab/GNbAC1 Antagonist of an Endogenous Retroviral Protein pHERV-W Env. Clin Ther. 2019 Sep;41(9):1737-1746. doi: 10.1016/j.clinthera.2019.05.020. Epub 2019 Jul 13.
PubMed 31311668
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
- NCT03574428
- Acronym / sponsor ID
- GNC-006
- Conditions
- Multiple Sclerosis
- Keywords
- Temelimab
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- GeNeuro Australia PTY LtdIndustry (pharma, biotech, devices)
- Study start
- 8 May 2018 (actual)
- Primary completion
- 2 Nov 2018 (actual)
- Study completion
- 2 Nov 2018 (actual)
- First posted
- 2 Jul 2018 (actual)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | Active comparator | Drug: GNbAC1, Other: GNbAC1 PlaceboGNbAC1 36 mg/kg single i.v. dose or GNbAC1 placebo |
| Cohort 2 | Active comparator | Drug: GNbAC1, Other: GNbAC1 PlaceboGNbAC1 60 mg/kg single i.v. dose or GNbAC1 placebo |
| Cohort 3 | Active comparator | Drug: GNbAC1, Other: GNbAC1 PlaceboGNbAC1 85 mg/kg single i.v. dose or GNbAC1 placebo |
| Cohort 4 | Active comparator | Drug: GNbAC1, Other: GNbAC1 PlaceboGNbAC1 110 mg/kg single i.v. dose or GNbAC1 placebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| GNbAC1Monoclonal Antibody infused i.v. | Drug | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
| GNbAC1 PlaceboEquivalent to GNbAC1 Buffer | Other | Cohort 1, Cohort 2, Cohort 3, Cohort 4 |
Primary outcome
Safety and tolerability of single ascending doses of GNbAC1 (Serious Adverse Events, Adverse Events)
Time frame: 57 days
Serious Adverse Events (SAE), Adverse Events (AE)
2 secondary outcomes
Pharmacokinetic (PK): GNbAC1 serum concentrations over time
Time frame: 57 days
Immunogenicity: Antibodies against GNbAC1 (ADA)
Time frame: 57 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.
- Derived from this study: PubMed 31311668Porchet H, Vidal V, Kornmann G, Malpass S, Curtin F. A High-dose Pharmacokinetic Study of a New IgG4 Monoclonal Antibody Temelimab/GNbAC1 Antagonist of an Endogenous Retroviral Protein pHERV-W Env. Clin Ther. 2019 Sep;41(9):1737-1746. doi: 10.1016/j.clinthera.2019.05.020. Epub 2019 Jul 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Multiple Sclerosis, run by GeNeuro Australia PTY Ltd at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Australia. 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 (Serious Adverse Events, Adverse Events) (time frame: 57 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 NCT03574428, 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.