NCT01587807

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Doses of Inhaled GSK1995057

A Two-part, Randomised, Placebo-controlled Study to Investigatethe Safety, Tolerability, Pharmacokinetics and Pharmacodynamicsof Single Doses of Inhaled GSK1995057 in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: GlaxoSmithKline · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

GSK1995057 is a fully human, single domain antibody directed against the TNFR1 receptor. The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of inhaled GSK1995057 in healthy subjects. The study will be in two parts. Part 1 is a single-dose escalating design of 5 sequential cohorts of healthy subjects. Part 2 is a single-dose, parallel group design comprising 2 groups of healthy subjects assessing the effect of GSK1995057 on lung inflammation following inhaled LPS challenge. Actual dose administered in Part 2 will be determined from emerging safety and PK data from Part 1 and Study TFR110951.

Detailed description

This study will be a randomised, placebo-controlled study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of single doses of inhaled GSK1995057 in healthy subjects. The study consists of 2 parts with a total of 6 cohorts. Part 1 will be conducted singleblind and Part 2 will be conducted single-blind with restrictions (i.e. subject and investigator only). The GSK Study Team and site pharmacist will remain unblinded to treatment allocation. Cohorts 1, 2, 3 and 4 (in Part 1) will receive a single inhaled dose of GSK1995057 or placebo. Cohort 5 will receive a single inhaled dose of GSK1995057 and in addition will have a bronchoalveolar lavage (BAL) sampling procedure conducted approximately 30 minutes post GSK1995057 dose. Subjects in Cohort 6 (Part 2) will be randomised to receive a high dose of GSK1995057 or placebo followed by an inhaled LPS challenge and BAL sampling procedure. Subjects will be required to visit the clinic over the course of 28 days after their dosing period for a follow up. Further visits for immunogenicity sampling may be conducted at 56 and 84 days post-first dose for subjects who show changes indicating a positive ADA response after dosing. Doses levels stipulated within the protocol are target doses based on predictions using the PK/PD model described in Section 1.2.2 of the clinical protocol. Part 1 will commence first and following acceptable safety and tolerability data will allow initiation of Part 2. All cohorts will participate in a single study session only.

Conditions

• Respiratory Disorders

Interventions

Type	Name	Description
DRUG	GSK1995057	inhaled dose (volume based on cohort)
PROCEDURE	bronchoalveolar lavage	BAL
DRUG	LPS	50 μg
DRUG	Placebo	Sucrose, glycine, sodium dihydrogen phosphate and polysorbate 80 (volume to match active dose)

Timeline

• Start date: 2012-03-28
• Primary completion: 2012-11-19
• Completion: 2012-11-19
• First posted: 2012-04-30
• Last updated: 2019-06-27

Locations

2 sites across 1 country: United Kingdom