AsthmaPhase 1NCT01563042
A Single Dose Pharmacokinetics (PK) Study of GSK2434735 in Healthy Male Volunteers
A Phase 1 study testing Intravenous (IV) single dose and Subcutaneous (SC) single dose in people with Asthma, run by GlaxoSmithKline at 1 site in United Kingdom.
Trial summary
An exploratory First Time in Human (FTIH) study investigating the pharmacokinetics, immunogenicity, safety and tolerability of GSK2434735 administered as a single low dose in healthy male subjects Read more about this study
- Who is it for?
- Ages 18 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- Intravenous (IV) single dose and Subcutaneous (SC) single dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 13 Feb 2012to 23 May 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 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male volunteers between 18 and 65 years of age
- Negative for pre-existing antibodies to GSK2434735.
- Body weight greater than and equal to 50 kg
- BMI 19 - 29.9 kg/m2.
- Lifelong non-smokers or ex-smokers of greater than 6 months
Who cannot join
- Clinically significant abnormalities.
- Current or past history of significant cardiac, respiratory, metabolic, renal, hepatic, neurological or gastrointestinal conditions.
- Current evidence or recent history of an infective illness.
- Vaccination within 3 weeks of screening
- History of severe allergic reactions, angio-oedema, anaphylaxis or immunodeficiency
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
GSK Investigational Site
Cambridge, Cambridgeshire, CB2 0QQ
About this study
Official title: An Exploratory First Time in Human (FTIH) Study Investigating the Pharmacokinetics (PK), Immunogenicity, Safety and Tolerability of GSK2434735 Administered as a Single Low Dose in Healthy Male Subjects
An exploratory First Time in Human (FTIH) study investigating the pharmacokinetics, immunogenicity, safety and tolerability of GSK2434735 administered as a single low dose in healthy male subjects
Read the detailed description
Interleukin-13 (IL-13) and IL-4 are mediators in the pathogenesis of established asthmatic disease. GSK2434735 is a bispecific antibody to IL-13 and IL-4. The purpose of this open label, sequential cohort, exploratory First Time in Human (FTIH) study is to evaluate the pharmacokinetics (PK) profile of GSK2434735 after a single low intravenous or subcutaneous dose in healthy male volunteers, and to assess if the pharmacokinetics (PK) parameters can be scaled from monkey to man. In addition, the safety and tolerability will be monitored and the study will assess if antibodies are generated to GSK2434735.
- Conditions
- Asthma
- Being tested
- Intravenous (IV) single dose, Subcutaneous (SC) single dose
- Keywords
- immunogenicity, GSK2434735, pharmacokinetics (PK), PK, biospecific antibody
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous (IV) single doseDrug
Also called GSK2434735
GSK2434735 administered as a single intervenous dose at the beginning of the study
Subcutaneous (SC) single doseDrug
Also called GSK2434735
GSK2434735 administered as a single subcutaneous dose at the beginning of the study
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 GSK2434735 | Experimental | Cohort 1: Single intravenous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose. Receives: Drug: Intravenous (IV) single dose |
| Cohort 2 GSK2434735 | Experimental | Cohort 2: Single subcutaneous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose. Receives: Drug: Subcutaneous (SC) single dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
Profile of Pharmacokinetics
Cmax, tmax, AUC, CL, t1/2
Measured: 42 days
Secondary outcomes (5)
Safety and tolerability of GSK2434735 as assessed by telemetry and change from baseline in 12-lead Electrocardiograms (ECG)
Change from baseline for PR, RR, QRS, QT, QTc measurements at Day 42
Measured: 42 days
Safety and tolerability of GSK2434735 as assessed by change from baseline in blood pressure and heart rate
Change from baseline for systolic and diastolic blood pressure and heart rate measurements at 42 Days
Measured: 42 days
Safety and tolerability of GSK2434735 as assessed by number of participants with adverse events
Clinically relevant changes from baseline in subject's disposition at Day 42
Measured: 42 days
Change from baseline for Clinical laboratory assessments (hematology, chemistry and urinalysis
Changes from baseline values of hematologic , chemistry and urinary testing parameters at Day 42
Measured: 42 days
Assessment of human anti-drug antibodies (ADA) in blood
Incidence of human anti-drug antibodies (ADA) at Day 42
Measured: 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study start13 Feb 2012
- Primary completion23 May 2012
- Study completion23 May 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 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
- NCT01563042
- Sponsor's protocol ID
- 114594
- Status last verified
- Jun 2017
- First submitted
- 15 Mar 2012
- Last updated
- 20 Jun 2017
- Results posted
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory First Time in Human (FTIH) Study Investigating the Pharmacokinetics (PK), Immunogenicity, Safety and Tolerability of GSK2434735 Administered as a Single Low Dose in Healthy Male Subjects
- ClinicalTrials.gov ID
- NCT01563042
- Acronym / sponsor ID
- 114594
- Conditions
- Asthma
- Keywords
- immunogenicity, GSK2434735, pharmacokinetics (PK), PK, biospecific antibody
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Feb 2012 (actual)
- Primary completion
- 23 May 2012 (actual)
- Study completion
- 23 May 2012 (actual)
- First posted
- 26 Mar 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.
An exploratory First Time in Human (FTIH) study investigating the pharmacokinetics, immunogenicity, safety and tolerability of GSK2434735 administered as a single low dose in healthy male subjects
Detailed description
Interleukin-13 (IL-13) and IL-4 are mediators in the pathogenesis of established asthmatic disease. GSK2434735 is a bispecific antibody to IL-13 and IL-4. The purpose of this open label, sequential cohort, exploratory First Time in Human (FTIH) study is to evaluate the pharmacokinetics (PK) profile of GSK2434735 after a single low intravenous or subcutaneous dose in healthy male volunteers, and to assess if the pharmacokinetics (PK) parameters can be scaled from monkey to man. In addition, the safety and tolerability will be monitored and the study will assess if antibodies are generated to GSK2434735.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 GSK2434735 | Experimental | Drug: Intravenous (IV) single doseCohort 1: Single intravenous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose. |
| Cohort 2 GSK2434735 | Experimental | Drug: Subcutaneous (SC) single doseCohort 2: Single subcutaneous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Healthy male volunteers between 18 and 65 years of age
- Negative for pre-existing antibodies to GSK2434735.
- Body weight greater than and equal to 50 kg
- BMI 19 - 29.9 kg/m2.
- Lifelong non-smokers or ex-smokers of greater than 6 months
Key exclusion criteria (5 listed)
- Clinically significant abnormalities.
- Current or past history of significant cardiac, respiratory, metabolic, renal, hepatic, neurological or gastrointestinal conditions.
- Current evidence or recent history of an infective illness.
- Vaccination within 3 weeks of screening
- History of severe allergic reactions, angio-oedema, anaphylaxis or immunodeficiency
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 |
|---|---|---|
| Intravenous (IV) single doseAlso: GSK2434735GSK2434735 administered as a single intervenous dose at the beginning of the study | Drug | Cohort 1 GSK2434735 |
| Subcutaneous (SC) single doseAlso: GSK2434735GSK2434735 administered as a single subcutaneous dose at the beginning of the study | Drug | Cohort 2 GSK2434735 |
Primary outcome
Profile of Pharmacokinetics
Time frame: 42 days
Cmax, tmax, AUC, CL, t1/2
5 secondary outcomes
Safety and tolerability of GSK2434735 as assessed by telemetry and change from baseline in 12-lead Electrocardiograms (ECG)
Time frame: 42 days
Safety and tolerability of GSK2434735 as assessed by change from baseline in blood pressure and heart rate
Time frame: 42 days
Safety and tolerability of GSK2434735 as assessed by number of participants with adverse events
Time frame: 42 days
Change from baseline for Clinical laboratory assessments (hematology, chemistry and urinalysis
Time frame: 42 days
Assessment of human anti-drug antibodies (ADA) in blood
Time frame: 42 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 Jun 2017.
- 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.
- Results for study 114594 can be found on the GSK Clinical Study Register.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 Intravenous (IV) single dose and Subcutaneous (SC) single dose in people with Asthma, 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 5 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 Jun 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?
Profile of Pharmacokinetics (time frame: 42 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 Jun 2017.