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
Sponsor study identifier
interventional
61
1 country
1
Study Start
May 30, 2011
Actual (reported)Primary Completion
September 30, 2011
Actual (reported)Study Completion
September 30, 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2011
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 30, 2011
Actual (reported)September 30, 2011
Actual (reported)September 30, 2011
Actual (reported)November 23, 2011
Actual (reported)November 28, 2011
Actual (reported)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.
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
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.
From pre-dose until 3 days post-dose
Systemic PK
From pre-dose until 3 days post-dose
Correlation Evaluation
From pre-dose until 3 days post-dose
2ng GSK2245053
Placebo
20ng GSK2445053
2ng GSK2445053 administered intranasally
20ng GSK2445053 administered intranasally
GSK Investigational Site
Zuidlaren, 9471 GP, Netherlands
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.
GSK Clinical Trials
GlaxoSmithKline
61 participants (actual enrollment reported by the registry).
First Submitted
November 23, 2011
First Posted
November 28, 2011
Study Start
May 30, 2011
Actual (reported)Clinical Trial of STAHIST in Seasonal Allergic Rhinitis Patients
Placebo
100ng GSK2445053
Placebo
200ng GSK2445053
Placebo
400ng GSK2445053
Placebo
1000ng GSK2245053
Placebo
2000ng GSK2445053
Placebo
4000ng GSK2445053
Placebo
100ng GSK2445053 administered intranasally
200ng GSK2445053 administered intranasally
400ng GSK2445053 administered intranasally
1000ng GSK2445053 administered intranasally
2000ng GSK2445053 administered intranasally
4000ng GSK2445053 administered intranasally
Placebo administered intranasally
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
September 30, 2011
Actual (reported)Study Completion
September 30, 2011
Actual (reported)Last Updated
June 28, 2017
Record last verified: 2017-06
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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Source: ClinicalTrials.gov.
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