HealthyPhase 1NCT02235727
Safety and Tolerability of GBR 900 in a Single Ascending Dose Study in Healthy Subjects
A Phase 1 study testing GBR 900 in people with Healthy, run by Glenmark Pharmaceuticals Ltd. India at 1 site in United Kingdom.
Trial summary
A Single Dose Study of GBR 900 in Healthy Volunteers. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- GBR 900
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jul 2014to Nov 2016
- 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
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be ≥ 50 kg.
- Men and women aged between 18 and 55 years (inclusive). Female subjects must be of non-child-bearing potential
- Subjects who are otherwise healthy and free from clinically significant illness or disease as determined by medical history, vital signs, physical examinations, and other tests performed by the investigator.
Who cannot join
- Subjects with a history of neuropathy or otherwise present with risk factors for neurological toxicity like chronic alcoholism or clinically significant neurological (e.g. dementia, cognitive decline, seizure disorders) or psychiatric disorders.
- Subjects with a recent history of live vaccination within the past 3 month or presence of active infections within the previous month.
- Subjects with previous exposure to antibody therapies or administration of immunoglobulins (Ig) within 6 months of randomization.
- Subjects with a history of or presence of inflammatory disease or rheumatological diseases or joint diseases including OA or any undiagnosed pain in joints.
- Subjects with a current and/or recent history of arthralgia or a history of fibromyalgia, migraine, neuralgia, or systemic painful conditions, or medical or arthritic conditions or any undiagnosed pain or systemic inflammatory disorders.
- Any evidence of organ dysfunction or any clinically significant deviation from the normal in history, physical or neurological determinations or investigations or has a clinical condition or receiving therapy that, in the opinion of the Investigator, would make the subjects unsuitable for study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Covance Clinical Research Unit Ltd
Leeds, Yorkshire, LS29LH
About this study
Official title: A Phase 1, Double-Blind, Randomised, Placebo-Controlled, Study to Evaluate the Safety and Pharmacokinetics of GBR 900 in Adult Healthy Volunteers
A Single Dose Study of GBR 900 in Healthy Volunteers.
Read the detailed description
This is a phase I study of GBR 900 in healthy volunteers. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Each participant will remain in the study for approximately 3.5 months. This study is for research purposes only and is not intended to treat any medical condition.
- Conditions
- Healthy
- Being tested
- GBR 900, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GBR 900Drug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| GBR 900 | Experimental | Test treatment GBR 900 Receives: Drug: GBR 900 |
| Placebo | Placebo comparator | Placebo Treatment Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drug related adverse events (AEs) or any serious AEs
All treatment - emergent adverse events (TEAEs), occuring during the study, in terms of nature, onset, duration, severity, relationship and outcome of adverse events and serious adverse events in adult healthy volunteers from baseline to day 71.
Measured: 71 days
Secondary outcomes (4)
Maximum Concentration (Cmax) of single ascending doses of GBR 900 in adult healthy volunteers
Measured: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Area Under Curve [(AUC (0-∞) and AUC (0-t)] of single ascending doses of GBR 900 in adult healthy volunteers
Measured: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Half life (t1/2) of single ascending doses of GBR 900 in adult healthy volunteers
Measured: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Immunogenicity of GBR 900
Measured: Pre-dose and at day 29, day 43, and day 71
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJul 2014
- Primary completionNov 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. India
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Responsible party
- Sponsor
- Investigators
- Jim Bush, MBChB, PhD, MRCS, Principal investigator, Covance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235727
- Sponsor's protocol ID
- GBR 900-101
- Other IDs
- 2013-005480-31
- Status last verified
- Jan 2017
- First submitted
- 7 Aug 2014
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Double-Blind, Randomised, Placebo-Controlled, Study to Evaluate the Safety and Pharmacokinetics of GBR 900 in Adult Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02235727
- Acronym / sponsor ID
- GBR 900-101
- Conditions
- Healthy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Glenmark Pharmaceuticals Ltd. IndiaIndustry (pharma, biotech, devices)
- Collaborators
- Glenmark Pharmaceuticals S.A.
- Study start
- Jul 2014
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 10 Sep 2014 (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.
A Single Dose Study of GBR 900 in Healthy Volunteers.
Detailed description
This is a phase I study of GBR 900 in healthy volunteers. The purposes of this study are to look at safety, how well the study drug is tolerated, how much of the study drug gets into the blood stream, and how long it takes the body to get rid of it when given to humans. Information about any side effects that may occur will also be collected. Each participant will remain in the study for approximately 3.5 months. This study is for research purposes only and is not intended to treat any medical condition.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GBR 900 | Experimental | Drug: GBR 900Test treatment GBR 900 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo Treatment |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) within the range 18.5-32 kg/m2 (inclusive); weight must be ≥ 50 kg.
- Men and women aged between 18 and 55 years (inclusive). Female subjects must be of non-child-bearing potential
- Subjects who are otherwise healthy and free from clinically significant illness or disease as determined by medical history, vital signs, physical examinations, and other tests performed by the investigator.
Key exclusion criteria (6 listed)
- Subjects with a history of neuropathy or otherwise present with risk factors for neurological toxicity like chronic alcoholism or clinically significant neurological (e.g. dementia, cognitive decline, seizure disorders) or psychiatric disorders.
- Subjects with a recent history of live vaccination within the past 3 month or presence of active infections within the previous month.
- Subjects with previous exposure to antibody therapies or administration of immunoglobulins (Ig) within 6 months of randomization.
- Subjects with a history of or presence of inflammatory disease or rheumatological diseases or joint diseases including OA or any undiagnosed pain in joints.
- Subjects with a current and/or recent history of arthralgia or a history of fibromyalgia, migraine, neuralgia, or systemic painful conditions, or medical or arthritic conditions or any undiagnosed pain or systemic inflammatory disorders.
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 |
|---|---|---|
| GBR 900 | Drug | GBR 900 |
| Placebo | Drug | Placebo |
Primary outcome
Drug related adverse events (AEs) or any serious AEs
Time frame: 71 days
All treatment - emergent adverse events (TEAEs), occuring during the study, in terms of nature, onset, duration, severity, relationship and outcome of adverse events and serious adverse events in adult healthy volunteers from baseline to day 71.
4 secondary outcomes
Maximum Concentration (Cmax) of single ascending doses of GBR 900 in adult healthy volunteers
Time frame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Area Under Curve [(AUC (0-∞) and AUC (0-t)] of single ascending doses of GBR 900 in adult healthy volunteers
Time frame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Half life (t1/2) of single ascending doses of GBR 900 in adult healthy volunteers
Time frame: Pre-dose and post-dose at planned multiple time points from 2 hours to 168 hours and from day 15 until day 71
Immunogenicity of GBR 900
Time frame: Pre-dose and at day 29, day 43, and day 71
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 24 Jan 2017.
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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.
Jim Bush, MBChB, PhD, MRCS principal investigator
Covance
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 GBR 900 in people with Healthy, run by Glenmark Pharmaceuticals Ltd. India at 1 site in United Kingdom.
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 3 inclusion and 6 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 24 Jan 2017. 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 United Kingdom. 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. 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?
Drug related adverse events (AEs) or any serious AEs (time frame: 71 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 24 Jan 2017.