Rhinitis, Allergic, SeasonalPhase 1NCT01480271
An Investigation of the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GSK2245035 in Healthy Volunteers and Allergic Rhinitics.
A Phase 1 study testing 2 ng GSK2445053, 20ng GSK2445053 and 100ng GSK2445053 in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site in Netherlands.
Trial summary
GSK2245035 is a highly selective Toll-like Receptor 7(TLR7) agonist capable of preferentially inducing the production of interferon alpha (IFNα) versus tumor necrosis factor alpha (TNFα). 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
- Rhinitis, Allergic, Seasonal
- What is being tested?
- 2 ng GSK2445053, 20ng GSK2445053 and 100ng GSK2445053
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteNetherlands
- Study dates
- 30 May 2011to 30 Sep 2011
- 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 as determined by a responsible and experienced physician, based on a medical evaluation including medical history,physical examination, laboratory testsand cardiac monitoring. A subject with a clinical abnormality or laboratoryparameters outside the reference range for the population being studied may be included only if the Investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male between 18 and 55 years of age inclusive, at the time of signing the informed consent.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1 of the protocol. This criterion must be followed from the time of the first dose of study medication until one week post-dosing.
- Body weight greater than or equal to 50 kilograms (kg) and Body Mass Index (BMI) within the range 19 - 29.9 kilograms per square metre (kg/m2) inclusive.
- 12 lead Electrocardiogram without any clinically significant abnormality as judged by the Investigator, and average QT interval (QTc), QT interval corrected for Basett (QTcB) or QT interval corrected for Fredericia (QTcF) less than 450 milliseconds
- Aspartate transaminase (AST), alanine transamine (ALT), alkaline phosphatase and bilirubin less than 1.5 x Upper Limit of Normal (ULN) (isolated bilirubin greater than1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin less than 35%).
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- Subjects have a screening pre-challenge Forced Expiratory Volume in 1 second (FEV1) greater than or equal to 80% and a baseline FEV1/FVC greater than or equal to 70% of the predicted value.
- Subjects should refrain from smoking between screening and the end of the study, and have a negative test for cotinine/ carbon monoxide (CO) at pre-dose.
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Available to complete all the required study measurements.
- History and diagnosis of symptomatic seasonal allergic rhinitis to pollen, for more than 3 years.
- Positive skin allergy test (wheal greater than or equal to 4miliimetres) or radioallergosorbent test (RAST) greater than or equal to Class 2, for pollen allergens.
- Subjects have a Total Nasal Symptom Score (TNSS) score of greater than or equal to 3 during the current pollen season (Total nasal symptom score is the sum of nasal congestion, rhinorrhoea, nasal itch and sneeze, each of which are scored on a scale from 0 to 3).
Who cannot join
- History of immunologic or haematologic deficiencies or diseases, except conditions that in the opinion of the Investigator and the GSK Medical Monitor are unlikely to introduce additional risk factors.
- Current diagnosis of asthma.
- Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations or history of frequent nosebleeds.
- History of haematologic, gastro-intestinal, hepatic, renal or other condition that may influence the absorption, distribution, metabolism, excretion or action of the drug.
- History of frequent headaches and/or migraine.
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
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- A positive test for Human Immunodeficiency Virus antibody
- A positive screening or pre-dose drug/alcohol screen, or a positive pre-dose smoking test
- History of regular alcohol consumption within 6 months of the study defined as: an average weekly intake of greater than 21 units for males or greater than 14 units for females. One unit is equivalent to 8 grams (8g) of alcohol: a half-pint or approximately 240 millilitres (240 mL) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
- The subject has participated in a clinical trial and has received an investigational product within 3 months prior to the first dosing day in the current study.
- Exposure to more than four new chemical entities within 6 months prior to the first dosing day.
- History of drug or other allergy that, in the opinion of the Investigator or GSK Medical Monitor, contraindicates participation in this study.
- Donation of blood or blood products in excess of 500 mL within a 90-day period.
- History of sensitivity to heparin or heparin-induced thrombocytopenia
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated
- History of rhinitis, including allergic, non-allergic rhinitis and rhinosinusitis. Subjects with recent upper respiratory tract infections (URTIs) will be allowed in the study only if their nasal symptoms have been completely resolved for more than 3 weeks prior to screening.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to entry to the clinic, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- Subjects with recent upper respiratory tract infections (URTIs) will be allowed in the study only if their nasal symptoms have been completely resolved for more than 3 weeks prior to screening.
- Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to entry into the clinic, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Subjects using treatment for allergies and AR may participate in the study if they remain free of medication for the following periods of time prior to entry into the clinic:
- Nasal antihistamines: 48 hours
- Oral antihistamines A (cetirizine, fexofenadine, loratadine, desloratadine): 72 hours
- Oral antihistamines B (all others): 72 hours
- Nasal decongestants: 24 hours
- Oral decongestants: 24 hours
- Nasal glucocorticosteroids: 4 weeks
- Oral glucocorticosteroids: 12 weeks
- Oral leukotriene receptor antagonists: 7 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-blind, Placebo-controlled First Time Into Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intranasal Dosing With GSK2245035, a TLR7 Agonist, in Healthy Volunteers and Allergic Rhinitics
GSK2245035 is a highly selective Toll-like Receptor 7(TLR7) agonist capable of preferentially inducing the production of interferon alpha (IFNα) versus tumor necrosis factor alpha (TNFα). The aim of this FTIH study is to collect tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) information to enable the identification of appropriate safe doses of intranasal (i.n) GSK2245035, associated with up-regulation of TLR7-mediated genes in the nasal milieu, for use in subsequent clinical drug development studies. There will be two parts to the study: Healthy Volunteers will be dosed in escalating single doses in Part 1, followed by Allergic Rhinitis (AR) subjects dosed similarly in Part 2.
Read the detailed description
This is a First Time in Human (FTIH) study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single, escalating doses of intranasal (i.n.) GSK2245035 in healthy male volunteers (HVT) and male subjects with allergic rhinitis (AR). The safety and tolerability of single i.n. GSK2245035 dosing will be assessed and established in HVT before the initiation of evaluation in AR.
GSK2245035 is a highly selective Toll-like Receptor 7 (TLR7) agonist capable of preferentially inducing the production of IFNα rather than TNFα. Activation of TLR7 is known to result in upregulation of co-stimulatory signals on antigen-presenting cells and in generation of pro-inflammatory mediators that can shift bystander immune responses towards a Helper T-cell Type 1/ Regulatory T cell (Th1/Treg) phenotype and therefore reduce the magnitude of Helper T-cell Type 2 (Th2) reactivity. In this context, it is proposed that i.n. GSK2245035 administration may alter the airways immune environment in a way that results in long-lasting control of AR symptoms and potentially disease remission through persistent modification of the underlying aberrant Th2 responsiveness to aeroallergens.
The aim of this study is to collect tolerability, PK and PD information to enable the identification of appropriate safe doses of i.n. GSK2245035, associated with up-regulation of TLR7-mediated genes in the nasal milieu, for use in subsequent clinical drug development studies. The study will be divided in to two parts. Part 1, involving only healthy volunteers, will consist of 8 cohorts receiving doses from 2 nanograms (2 ng) to 4000ng or a placebo dose. Administration within each cohort will be staggered so that two subjects (one receiving drug and one placebo) will be dosed and monitored for 24 hours before any subsequent doses.
Screening for part 2 of the study will begin once data from cohort 4 in part 1 has been found to be satisfactory. Part 2 will involve subjects with Allergic Rhinitis and be divided into three cohorts receiving doses between 20ng and 4000ng or a placebo dose.
- Conditions
- Rhinitis, Allergic, Seasonal
- Being tested
- 2 ng GSK2445053, 20ng GSK2445053, 100ng GSK2445053, 200ng GSK2445053, 400ng GSK2445053
- Keywords
- Allergic Rhinitis, Healthy Volunteers, Single Dose Escalation, TLR7 agonist, First Time in Human Study
- Medical subject headings
- Rhinitis, Allergic, Seasonal, Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2 ng GSK2445053Drug
2ng GSK2445053 administered intranasally
20ng GSK2445053Drug
20ng GSK2445053 administered intranasally
100ng GSK2445053Drug
100ng GSK2445053 administered intranasally
200ng GSK2445053Drug
200ng GSK2445053 administered intranasally
400ng GSK2445053Drug
400ng GSK2445053 administered intranasally
1000ng GSK2445053Drug
1000ng GSK2445053 administered intranasally
2000ng GSK2445053Drug
2000ng GSK2445053 administered intranasally
4000ng GSK2445053Drug
4000ng GSK2445053 administered intranasally
PlaceboDrug
Placebo administered intranasally
| Study group | Role | What they receive |
|---|---|---|
| Part 1 Cohort 1 GSK2445053 | Experimental | 2ng GSK2245053 Receives: Drug: 2 ng GSK2445053 |
| Part 1 Cohort 1 Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Part 1 Cohort 2 GSK2445053 | Experimental | 20ng GSK2445053 Receives: Drug: 20ng GSK2445053 |
| Part 1 Cohort 2 Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Part 1 Cohort 3 GSK2245053 | Experimental | 100ng GSK2445053 Receives: Drug: 100ng GSK2445053 |
| Part 1 Cohort 3 Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Part 1 Cohort 4 GSK2445053 | Experimental | 200ng GSK2445053 Receives: Drug: 200ng GSK2445053 |
| Part 1 Cohort 4 Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Part 1 Cohort 5 GSK245053 | Experimental | 400ng GSK2445053 Receives: Drug: 400ng GSK2445053 |
| Part 1 Cohort 5 Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Part 1 Cohort 6 GSK2445053 | Experimental | 1000ng GSK2245053 Receives: Drug: 1000ng GSK2445053 |
| Part 1 Cohort 6 Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Part 1 Cohort 7 GSK2445053 | Experimental | 2000ng GSK2445053 Receives: Drug: 2000ng GSK2445053 |
| Part 1 Cohort 7 Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
| Part 1 Cohort 8 GSK2445053 | Experimental | 4000ng GSK2445053 Receives: Drug: 4000ng GSK2445053 |
| Part 1 Cohort 8 Placebo | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
General safety endpoints, including AEs, vital signs, 12-lead ECG, body temperature and clinical laboratory safety tests to evaluate the safety and nasal tolerability of single escalation doses of GSK2245035 in healthy volunteers and individuals with Allergic Rhinitis.
Measured: From screening until follow-up
Nasal Tolerability
Nasal examination and nasal symptom to assess nasal tolerability of single escalating doses of GSK2245035 in subjects with Allergic Rhinitis
Measured: From screening until follow-up
TLR7-associated Biomarkers
Evaluation of the induction of TLR7-induced blood biomarkers in the nasal lavage and nasal tissues of individuals with AR following single GSK2245035 administration versus placebo.
Measured: From pre-dose until 3 days post-dose
Secondary outcomes (2)
Systemic PK
Standard single dose derived plasma PK parameters for GSK2245035 in healthy volunteers and individuals with Allergic Rhinitis
Measured: From pre-dose until 3 days post-dose
Correlation Evaluation
To evaluate the correlation between GSK2245035 dose - systemic PK - PD blood biomarkers - PD nasal biomarkers in healthy volunteer and subjects with Allergic Rhinitis.
Measured: From pre-dose until 3 days post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2011 (estimated)
- Study start30 May 2011
- Primary completion30 Sep 2011
- Study completion30 Sep 2011
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 Rhinitis, Allergic, SeasonalStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 61 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
- NCT01480271
- Sponsor's protocol ID
- 114450
- Status last verified
- Jun 2017
- First submitted
- 23 Nov 2011
- Last updated
- 28 Jun 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
Tsitoura D, Ambery C, Price M, Powley W, Garthside S, Biggadike K, Quint D. Early clinical evaluation of the intranasal TLR7 agonist GSK2245035: Use of translational biomarkers to guide dosing and confirm target engagement. Clin Pharmacol Ther. 2015 Oct;98(4):369-80. doi: 10.1002/cpt.157.
PubMed 26044169
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled First Time Into Human Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intranasal Dosing With GSK2245035, a TLR7 Agonist, in Healthy Volunteers and Allergic Rhinitics
- ClinicalTrials.gov ID
- NCT01480271
- Acronym / sponsor ID
- 114450
- Conditions
- Rhinitis, Allergic, Seasonal
- Keywords
- Allergic Rhinitis, Healthy Volunteers, Single Dose Escalation, TLR7 agonist, First Time in Human Study
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 30 May 2011 (actual)
- Primary completion
- 30 Sep 2011 (actual)
- Study completion
- 30 Sep 2011 (actual)
- First posted
- 28 Nov 2011 (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.
GSK2245035 is a highly selective Toll-like Receptor 7(TLR7) agonist capable of preferentially inducing the production of interferon alpha (IFNα) versus tumor necrosis factor alpha (TNFα). The aim of this FTIH study is to collect tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) information to enable the identification of appropriate safe doses of intranasal (i.n) GSK2245035, associated with up-regulation of TLR7-mediated genes in the nasal milieu, for use in subsequent clinical drug development studies. There will be two parts to the study: Healthy Volunteers will be dosed in escalating single doses in Part 1, followed by Allergic Rhinitis (AR) subjects dosed similarly in Part 2.
Detailed description
This is a First Time in Human (FTIH) study to investigate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single, escalating doses of intranasal (i.n.) GSK2245035 in healthy male volunteers (HVT) and male subjects with allergic rhinitis (AR). The safety and tolerability of single i.n. GSK2245035 dosing will be assessed and established in HVT before the initiation of evaluation in AR.
GSK2245035 is a highly selective Toll-like Receptor 7 (TLR7) agonist capable of preferentially inducing the production of IFNα rather than TNFα. Activation of TLR7 is known to result in upregulation of co-stimulatory signals on antigen-presenting cells and in generation of pro-inflammatory mediators that can shift bystander immune responses towards a Helper T-cell Type 1/ Regulatory T cell (Th1/Treg) phenotype and therefore reduce the magnitude of Helper T-cell Type 2 (Th2) reactivity. In this context, it is proposed that i.n. GSK2245035 administration may alter the airways immune environment in a way that results in long-lasting control of AR symptoms and potentially disease remission through persistent modification of the underlying aberrant Th2 responsiveness to aeroallergens.
The aim of this study is to collect tolerability, PK and PD information to enable the identification of appropriate safe doses of i.n. GSK2245035, associated with up-regulation of TLR7-mediated genes in the nasal milieu, for use in subsequent clinical drug development studies. The study will be divided in to two parts. Part 1, involving only healthy volunteers, will consist of 8 cohorts receiving doses from 2 nanograms (2 ng) to 4000ng or a placebo dose. Administration within each cohort will be staggered so that two subjects (one receiving drug and one placebo) will be dosed and monitored for 24 hours before any subsequent doses.
Screening for part 2 of the study will begin once data from cohort 4 in part 1 has been found to be satisfactory. Part 2 will involve subjects with Allergic Rhinitis and be divided into three cohorts receiving doses between 20ng and 4000ng or a placebo dose.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 16
| Arm | Type | Receives |
|---|---|---|
| Part 1 Cohort 1 GSK2445053 | Experimental | Drug: 2 ng GSK24450532ng GSK2245053 |
| Part 1 Cohort 1 Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Part 1 Cohort 2 GSK2445053 | Experimental | Drug: 20ng GSK244505320ng GSK2445053 |
| Part 1 Cohort 2 Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Part 1 Cohort 3 GSK2245053 | Experimental | Drug: 100ng GSK2445053100ng GSK2445053 |
| Part 1 Cohort 3 Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Part 1 Cohort 4 GSK2445053 | Experimental | Drug: 200ng GSK2445053200ng GSK2445053 |
| Part 1 Cohort 4 Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Part 1 Cohort 5 GSK245053 | Experimental | Drug: 400ng GSK2445053400ng GSK2445053 |
| Part 1 Cohort 5 Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Part 1 Cohort 6 GSK2445053 | Experimental | Drug: 1000ng GSK24450531000ng GSK2245053 |
| Part 1 Cohort 6 Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Part 1 Cohort 7 GSK2445053 | Experimental | Drug: 2000ng GSK24450532000ng GSK2445053 |
| Part 1 Cohort 7 Placebo | Placebo comparator | Drug: PlaceboPlacebo |
| Part 1 Cohort 8 GSK2445053 | Experimental | Drug: 4000ng GSK24450534000ng GSK2445053 |
| Part 1 Cohort 8 Placebo | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history,physical examination, laboratory testsand cardiac monitoring. A subject with a clinical abnormality or laboratoryparameters outside the reference range for the population being studied may be included only if the Investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
- Male between 18 and 55 years of age inclusive, at the time of signing the informed consent.
- Male subjects with female partners of child-bearing potential must agree to use one of the contraception methods listed in Section 8.1 of the protocol. This criterion must be followed from the time of the first dose of study medication until one week post-dosing.
- Body weight greater than or equal to 50 kilograms (kg) and Body Mass Index (BMI) within the range 19 - 29.9 kilograms per square metre (kg/m2) inclusive.
- 12 lead Electrocardiogram without any clinically significant abnormality as judged by the Investigator, and average QT interval (QTc), QT interval corrected for Basett (QTcB) or QT interval corrected for Fredericia (QTcF) less than 450 milliseconds
Key exclusion criteria (28 listed)
- History of immunologic or haematologic deficiencies or diseases, except conditions that in the opinion of the Investigator and the GSK Medical Monitor are unlikely to introduce additional risk factors.
- Current diagnosis of asthma.
- Nasal conditions likely to affect the outcome of the study, i.e. nasal septal perforation, nasal polyps, other nasal malformations or history of frequent nosebleeds.
- History of haematologic, gastro-intestinal, hepatic, renal or other condition that may influence the absorption, distribution, metabolism, excretion or action of the drug.
- History of frequent headaches and/or migraine.
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 |
|---|---|---|
| 2 ng GSK24450532ng GSK2445053 administered intranasally | Drug | Part 1 Cohort 1 GSK2445053 |
| 20ng GSK244505320ng GSK2445053 administered intranasally | Drug | Part 1 Cohort 2 GSK2445053 |
| 100ng GSK2445053100ng GSK2445053 administered intranasally | Drug | Part 1 Cohort 3 GSK2245053 |
| 200ng GSK2445053200ng GSK2445053 administered intranasally | Drug | Part 1 Cohort 4 GSK2445053 |
| 400ng GSK2445053400ng GSK2445053 administered intranasally | Drug | Part 1 Cohort 5 GSK245053 |
| 1000ng GSK24450531000ng GSK2445053 administered intranasally | Drug | Part 1 Cohort 6 GSK2445053 |
| 2000ng GSK24450532000ng GSK2445053 administered intranasally | Drug | Part 1 Cohort 7 GSK2445053 |
| 4000ng GSK24450534000ng GSK2445053 administered intranasally | Drug | Part 1 Cohort 8 GSK2445053 |
| PlaceboPlacebo administered intranasally | Drug | Part 1 Cohort 1 Placebo, Part 1 Cohort 2 Placebo, Part 1 Cohort 3 Placebo, Part 1 Cohort 4 Placebo, Part 1 Cohort 5 Placebo, Part 1 Cohort 6 Placebo, Part 1 Cohort 7 Placebo, Part 1 Cohort 8 Placebo |
Primary outcome
Safety
Time frame: From screening until follow-up
General safety endpoints, including AEs, vital signs, 12-lead ECG, body temperature and clinical laboratory safety tests to evaluate the safety and nasal tolerability of single escalation doses of GSK2245035 in healthy volunteers and individuals with Allergic Rhinitis.
Nasal Tolerability
Time frame: From screening until follow-up
Nasal examination and nasal symptom to assess nasal tolerability of single escalating doses of GSK2245035 in subjects with Allergic Rhinitis
TLR7-associated Biomarkers
Time frame: From pre-dose until 3 days post-dose
Evaluation of the induction of TLR7-induced blood biomarkers in the nasal lavage and nasal tissues of individuals with AR following single GSK2245035 administration versus placebo.
2 secondary outcomes
Systemic PK
Time frame: From pre-dose until 3 days post-dose
Correlation Evaluation
Time frame: From pre-dose until 3 days 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 28 Jun 2017.
- Derived from this study: PubMed 26044169Tsitoura D, Ambery C, Price M, Powley W, Garthside S, Biggadike K, Quint D. Early clinical evaluation of the intranasal TLR7 agonist GSK2245035: Use of translational biomarkers to guide dosing and confirm target engagement. Clin Pharmacol Ther. 2015 Oct;98(4):369-80. doi: 10.1002/cpt.157.
- Results for study 114450 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 2 ng GSK2445053, 20ng GSK2445053 and 100ng GSK2445053 in people with Rhinitis, Allergic, Seasonal, run by GlaxoSmithKline at 1 site in Netherlands.
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 13 inclusion and 28 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 28 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 Netherlands. 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?
Safety (time frame: From screening until follow-up). The study lists 3 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 NCT01480271, 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 28 Jun 2017.