Respiratory DisordersPhase 1NCT01818024
A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers
A Phase 1 study testing Single IV dose of GSK2862277, Single IH dose of GSK2862277 and Repeat IV dose of GSK2862277 in people with Respiratory Disorders, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or intravenous (IV) routes in healthy subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Disorders
- What is being tested?
- Single IV dose of GSK2862277, Single IH dose of GSK2862277 and Repeat IV dose of GSK2862277
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 Feb 2013to 25 Oct 2013
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Subject is positive at screening for HAVH autoantibodies against GSK1995057 (Part 1 only).
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Who cannot join
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Harrow, Middlesex, HA13UJ
About this study
Official title: A Three Part, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of Inhaled and Intravenous GSK2862277 in Healthy Volunteers
This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or intravenous (IV) routes in healthy subjects.
Part 1 of this study will involve an initial assessment of safety, tolerability and pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will occur which will assess key comparability criteria to inform progression to Part 2 of the study.
Read more
Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes of administration, in sequential manner, respectively. An interim data review will also occur after completion of Part 2, where all data accumulated previously will be assessed to examine appropriateness to progress to Part 3.
Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous routes using the same dose administered in Part 2.
- Conditions
- Respiratory Disorders
- Being tested
- Single IV dose of GSK2862277, Matching placebo single dose IV infusion, Single IH dose of GSK2862277, Matching placebo single dose IH, Repeat IV dose of GSK2862277
- Keywords
- healthy volunteer, TNFR1, domain antibody, Lung injury
- Medical subject headings
- Respiration Disorders, Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single IV dose of GSK2862277Drug
GSK2862277 solution available in a 40 mg vial for IV administration.
Matching placebo single dose IV infusionDrug
Matching placebo solution available for IV administration.
Single IH dose of GSK2862277Drug
GSK2862277 nebulised solution available in a 40 mg vial for IH administration.
Matching placebo single dose IHDrug
Matching placebo nebulised solution available for IH administration.
Repeat IV dose of GSK2862277Drug
GSK2862277 solution available in a 40 mg vial for IV administration.
Matching placebo repeat dose IV infusionDrug
Matching placebo solution available for IV administration.
Repeat IH dose selected of GSK2862277 from Part 2Drug
GSK2862277 nebulised solution available in a 40 mg vial for IH administration.
Matching placebo repeat dose IHDrug
Matching placebo nebulised solution available for IH administration.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Cohort 1a | Experimental | Single IV dose of GSK2862277 as a continuous infusion over 2 hours. Receives: Drug: Single IV dose of GSK2862277 |
| Part 1: Cohort 1b | Experimental | Single IV dose of GSK2862277 as a continuous infusion over 3 hours. Receives: Drug: Single IV dose of GSK2862277 |
| Part 1: Cohort 1c | Experimental | Single IV dose of GSK2862277 as a continuous infusion over 3 hours. Receives: Drug: Single IV dose of GSK2862277 |
| Part 2: Cohort 2a GSK2862277 | Experimental | Single IV dose of GSK2862277 as a continuous infusion over 1 hour. Receives: Drug: Single IV dose of GSK2862277 |
| Part 2: Cohort 2a Placebo | Experimental | Matching placebo will be administered as a continuous IV infusion over 1 hour. Receives: Drug: Matching placebo single dose IV infusion |
| Part 2: Cohort 2b GSK2862277 | Experimental | Single IH dose of GSK2862277. Receives: Drug: Single IH dose of GSK2862277 |
| Part 2: Cohort 2b Placebo | Experimental | Matching placebo will be administered. Receives: Drug: Matching placebo single dose IH |
| Part 3: Cohort 3a GSK2862277 | Experimental | IV dose of GSK2862277 (decided from Part 2) as a continuous infusion over 1 hour for daily 5 days. Receives: Drug: Repeat IV dose of GSK2862277 |
| Part 3: Cohort 3a Placebo | Experimental | Matching placebo will be administered as IV infusion over 1 hour daily for 5 days. Receives: Drug: Matching placebo repeat dose IV infusion |
| Part 3: Cohort 3b GSK2862277 | Experimental | Repeat IH dose of GSK2862277 (decided from Part 2) daily for 5 days. Receives: Drug: Repeat IH dose selected of GSK2862277 from Part 2 |
| Part 3: Cohort 3b Placebo | Experimental | Matching placebo will be administered as IH daily for 5 days. Receives: Drug: Matching placebo repeat dose IH |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by number of subjects with adverse events (AE)s in Part 1 and Part 2
Safety and tolerability parameters will include recording of adverse events (AEs), throughout the study.
Measured: Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by number of subjects with AEs in Part 3
Safety and tolerability parameters will include recording of AEs, throughout the study.
Measured: Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by laboratory tests in Part 1 and Part 2
Laboratory tests will include haemogram, clinical chemistry, urine examination.
Measured: Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 as assessed by laboratory tests in Part 3
Laboratory tests will include haemogram, clinical chemistry, urine examination.
Measured: Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by vital signs in Part 1 and Part 2
Vital signs will include blood pressure (BP), heart rate respiration rate and body temperature.
Measured: Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by vital signs in Part 3
Vital signs will include BP, heart rate respiration rate and body temperature.
Measured: Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by ECG in Part 1 and Part 2
Safety data will include electrocardiogram (ECG) readings obtained at each timepoint during the study.
Measured: Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by ECG in Part 3
Safety data will include ECG readings obtained at each timepoint during the study.
Measured: Up to 42 days
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by spirometry monitoring in Part 1 and Part 2
Spirometry monitoring will include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).
Measured: Up to 42 days
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by spirometry monitoring in Part 3
Spirometry monitoring will include FEV1 and FVC.
Measured: Up to 42 days
Safety and tolerability of single IV dose of GSK2862277 as assessed by measurement of plasma cytokines in Part 1
Blood samples will be collected for assessment of plasma cytokines.
Measured: Up to 42 days
Immunogenicity in subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
Presence of anti GSK2862277 binding antibodies will be evaluated.
Measured: Up to 60 days
Immunogenicity in subjects receiving repeat IV or IH dose of GSK2862277 in Part 3
Presence of anti GSK2862277 binding antibodies will be evaluated.
Measured: Up to 60 days
Secondary outcomes (8)
Pharmacokinetic (PK) parameters in subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
The blood samples will be collected for plasma concentrations of GSK2862277.
Measured: Up to 48 hours post dose
PK parameters in subjects receiving repeat IV dose of GSK2862277 in Part 3 Cohort 3a
The blood samples will be collected for plasma concentrations of GSK2862277.
Measured: Up to 48 hours post last dose
PK parameters in subjects receiving repeat IH dose of GSK2862277 in Part 3 Cohort 3b
The blood samples will be collected for plasma concentrations of GSK2862277
Measured: Up to 48 hours post last dose
PK parameters in subjects receiving single IV dose of GSK2862277 in Part 1
The PK parameters will be compared with historic GSK1995057 PK data in Part 1
Measured: Up to 48 hours post last dose
Pharmacodynamic and immune function biomarkers in serum of subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
The pharmacodynamic and immune function biomarkers in serum.
Measured: Up to 48 hours post last dose
Pharmacodynamic and immune function biomarkers in serum of subjects receiving repeat IV or IH dose of GSK2862277in Part 3
The pharmacodynamic and immune function biomarkers in serum.
Measured: Up to 48 hours post last dose
Change from baseline in IL-8 expression in ex vivo WBA in subjects receiving single IV 0.05 mg/kg dose of GSK2862277 in Part 1 in Cohort1c
IL-8 expression in ex vivo whole blood essay (WBA).
Measured: Up to 12 hours post dose
Composite of urine parameters in subjects receiving single IV 2 mg/kg dose of GSK2862277 in Part 2 in Cohort 2a
The urine samples will be collected for urine concentrations of GSK2862277.
Measured: Up to 48 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study start22 Feb 2013
- Primary completion25 Oct 2013
- Study completion25 Oct 2013
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 Respiratory DisordersStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818024
- Sponsor's protocol ID
- 116343
- Status last verified
- May 2017
- First submitted
- 14 Feb 2013
- Last updated
- 15 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Cordy JC, Morley PJ, Wright TJ, Birchler MA, Lewis AP, Emmins R, Chen YZ, Powley WM, Bareille PJ, Wilson R, Tonkyn J, Bayliffe AI, Lazaar AL. Specificity of human anti-variable heavy (VH ) chain autoantibodies and impact on the design and clinical testing of a VH domain antibody antagonist of tumour necrosis factor-alpha receptor 1. Clin Exp Immunol. 2015 Nov;182(2):139-48. doi: 10.1111/cei.12680. Epub 2015 Sep 11.
PubMed 26178412
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Three Part, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of Inhaled and Intravenous GSK2862277 in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01818024
- Acronym / sponsor ID
- 116343
- Conditions
- Respiratory Disorders
- Keywords
- healthy volunteer, TNFR1, domain antibody, Lung injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 22 Feb 2013 (actual)
- Primary completion
- 25 Oct 2013 (actual)
- Study completion
- 25 Oct 2013 (actual)
- First posted
- 26 Mar 2013 (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.
This will be a 3 part study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and repeat doses of GSK2862277 administered via inhalation (IH) or intravenous (IV) routes in healthy subjects.
Part 1 of this study will involve an initial assessment of safety, tolerability and pharmacokinetics of GSK286227, via single escalating intravenous doses, compared to a predecessor molecule, GSK1995057. After completion of Part 1 an interim data review will occur which will assess key comparability criteria to inform progression to Part 2 of the study.
Part 2 of the study will involve single doses of GSK2862277 at a level predicted to be at or close to therapeutic dose levels. Part 2 will investigate both intravenous and inhaled routes of administration, in sequential manner, respectively. An interim data review will also occur after completion of Part 2, where all data accumulated previously will be assessed to examine appropriateness to progress to Part 3.
Part 3 of the study will involve 5 days of repeat dosing via both inhaled and intravenous routes using the same dose administered in Part 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 11
| Arm | Type | Receives |
|---|---|---|
| Part 1: Cohort 1a | Experimental | Drug: Single IV dose of GSK2862277Single IV dose of GSK2862277 as a continuous infusion over 2 hours. |
| Part 1: Cohort 1b | Experimental | Drug: Single IV dose of GSK2862277Single IV dose of GSK2862277 as a continuous infusion over 3 hours. |
| Part 1: Cohort 1c | Experimental | Drug: Single IV dose of GSK2862277Single IV dose of GSK2862277 as a continuous infusion over 3 hours. |
| Part 2: Cohort 2a GSK2862277 | Experimental | Drug: Single IV dose of GSK2862277Single IV dose of GSK2862277 as a continuous infusion over 1 hour. |
| Part 2: Cohort 2a Placebo | Experimental | Drug: Matching placebo single dose IV infusionMatching placebo will be administered as a continuous IV infusion over 1 hour. |
| Part 2: Cohort 2b GSK2862277 | Experimental | Drug: Single IH dose of GSK2862277Single IH dose of GSK2862277. |
| Part 2: Cohort 2b Placebo | Experimental | Drug: Matching placebo single dose IHMatching placebo will be administered. |
| Part 3: Cohort 3a GSK2862277 | Experimental | Drug: Repeat IV dose of GSK2862277IV dose of GSK2862277 (decided from Part 2) as a continuous infusion over 1 hour for daily 5 days. |
| Part 3: Cohort 3a Placebo | Experimental | Drug: Matching placebo repeat dose IV infusionMatching placebo will be administered as IV infusion over 1 hour daily for 5 days. |
| Part 3: Cohort 3b GSK2862277 | Experimental | Drug: Repeat IH dose selected of GSK2862277 from Part 2Repeat IH dose of GSK2862277 (decided from Part 2) daily for 5 days. |
| Part 3: Cohort 3b Placebo | Experimental | Drug: Matching placebo repeat dose IHMatching placebo will be administered as IH daily for 5 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator and the GSK Medical Monitor agree that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Subject is positive at screening for HAVH autoantibodies against GSK1995057 (Part 1 only).
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive pre-study drug/alcohol screen.
Key exclusion criteria (4 listed)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
- A positive pre-study drug/alcohol screen.
- A positive test for human immunodeficiency virus (HIV) antibody.
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day
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 |
|---|---|---|
| Single IV dose of GSK2862277GSK2862277 solution available in a 40 mg vial for IV administration. | Drug | Part 1: Cohort 1a, Part 1: Cohort 1b, Part 1: Cohort 1c, Part 2: Cohort 2a GSK2862277 |
| Matching placebo single dose IV infusionMatching placebo solution available for IV administration. | Drug | Part 2: Cohort 2a Placebo |
| Single IH dose of GSK2862277GSK2862277 nebulised solution available in a 40 mg vial for IH administration. | Drug | Part 2: Cohort 2b GSK2862277 |
| Matching placebo single dose IHMatching placebo nebulised solution available for IH administration. | Drug | Part 2: Cohort 2b Placebo |
| Repeat IV dose of GSK2862277GSK2862277 solution available in a 40 mg vial for IV administration. | Drug | Part 3: Cohort 3a GSK2862277 |
| Matching placebo repeat dose IV infusionMatching placebo solution available for IV administration. | Drug | Part 3: Cohort 3a Placebo |
| Repeat IH dose selected of GSK2862277 from Part 2GSK2862277 nebulised solution available in a 40 mg vial for IH administration. | Drug | Part 3: Cohort 3b GSK2862277 |
| Matching placebo repeat dose IHMatching placebo nebulised solution available for IH administration. | Drug | Part 3: Cohort 3b Placebo |
Primary outcome
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by number of subjects with adverse events (AE)s in Part 1 and Part 2
Time frame: Up to 42 days
Safety and tolerability parameters will include recording of adverse events (AEs), throughout the study.
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by number of subjects with AEs in Part 3
Time frame: Up to 42 days
Safety and tolerability parameters will include recording of AEs, throughout the study.
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by laboratory tests in Part 1 and Part 2
Time frame: Up to 42 days
Laboratory tests will include haemogram, clinical chemistry, urine examination.
Safety and tolerability of repeat IV or IH dose of GSK2862277 as assessed by laboratory tests in Part 3
Time frame: Up to 42 days
Laboratory tests will include haemogram, clinical chemistry, urine examination.
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by vital signs in Part 1 and Part 2
Time frame: Up to 42 days
Vital signs will include blood pressure (BP), heart rate respiration rate and body temperature.
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by vital signs in Part 3
Time frame: Up to 42 days
Vital signs will include BP, heart rate respiration rate and body temperature.
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by ECG in Part 1 and Part 2
Time frame: Up to 42 days
Safety data will include electrocardiogram (ECG) readings obtained at each timepoint during the study.
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by ECG in Part 3
Time frame: Up to 42 days
Safety data will include ECG readings obtained at each timepoint during the study.
Safety and tolerability of single IV or IH dose of GSK2862277 assessed by spirometry monitoring in Part 1 and Part 2
Time frame: Up to 42 days
Spirometry monitoring will include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).
Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by spirometry monitoring in Part 3
Time frame: Up to 42 days
Spirometry monitoring will include FEV1 and FVC.
Safety and tolerability of single IV dose of GSK2862277 as assessed by measurement of plasma cytokines in Part 1
Time frame: Up to 42 days
Blood samples will be collected for assessment of plasma cytokines.
Immunogenicity in subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
Time frame: Up to 60 days
Presence of anti GSK2862277 binding antibodies will be evaluated.
Immunogenicity in subjects receiving repeat IV or IH dose of GSK2862277 in Part 3
Time frame: Up to 60 days
Presence of anti GSK2862277 binding antibodies will be evaluated.
8 secondary outcomes
Pharmacokinetic (PK) parameters in subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
Time frame: Up to 48 hours post dose
PK parameters in subjects receiving repeat IV dose of GSK2862277 in Part 3 Cohort 3a
Time frame: Up to 48 hours post last dose
PK parameters in subjects receiving repeat IH dose of GSK2862277 in Part 3 Cohort 3b
Time frame: Up to 48 hours post last dose
PK parameters in subjects receiving single IV dose of GSK2862277 in Part 1
Time frame: Up to 48 hours post last dose
Pharmacodynamic and immune function biomarkers in serum of subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2
Time frame: Up to 48 hours post last dose
Pharmacodynamic and immune function biomarkers in serum of subjects receiving repeat IV or IH dose of GSK2862277in Part 3
Time frame: Up to 48 hours post last dose
Change from baseline in IL-8 expression in ex vivo WBA in subjects receiving single IV 0.05 mg/kg dose of GSK2862277 in Part 1 in Cohort1c
Time frame: Up to 12 hours post dose
Composite of urine parameters in subjects receiving single IV 2 mg/kg dose of GSK2862277 in Part 2 in Cohort 2a
Time frame: Up to 48 hours post dose
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 15 May 2017.
- Derived from this study: PubMed 26178412Cordy JC, Morley PJ, Wright TJ, Birchler MA, Lewis AP, Emmins R, Chen YZ, Powley WM, Bareille PJ, Wilson R, Tonkyn J, Bayliffe AI, Lazaar AL. Specificity of human anti-variable heavy (VH ) chain autoantibodies and impact on the design and clinical testing of a VH domain antibody antagonist of tumour necrosis factor-alpha receptor 1. Clin Exp Immunol. 2015 Nov;182(2):139-48. doi: 10.1111/cei.12680. Epub 2015 Sep 11.
- Results for study 116343 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
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 Single IV dose of GSK2862277, Single IH dose of GSK2862277 and Repeat IV dose of GSK2862277 in people with Respiratory Disorders, run by GlaxoSmithKline 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 7 inclusion and 4 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 15 May 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. 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 IV or IH dose of GSK2862277 assessed by number of subjects with adverse events (AE)s in Part 1 and Part 2 (time frame: Up to 42 days). The study lists 13 primary outcomes in all. 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 NCT01818024, 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 15 May 2017.