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A Study to Investigate the Safety Tolerability Pharmacokinetics, and Pharmacodynamics of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

NCT ID: NCT01818024

Last Updated: 2017-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-22

Study Completion Date

2013-10-25

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Part 1: Cohort 1a

Single IV dose of GSK2862277 as a continuous infusion over 2 hours.

Group Type EXPERIMENTAL

Single IV dose of GSK2862277

Intervention Type DRUG

GSK2862277 solution available in a 40 mg vial for IV administration.

Part 1: Cohort 1b

Single IV dose of GSK2862277 as a continuous infusion over 3 hours.

Group Type EXPERIMENTAL

Single IV dose of GSK2862277

Intervention Type DRUG

GSK2862277 solution available in a 40 mg vial for IV administration.

Part 1: Cohort 1c

Single IV dose of GSK2862277 as a continuous infusion over 3 hours.

Group Type EXPERIMENTAL

Single IV dose of GSK2862277

Intervention Type DRUG

GSK2862277 solution available in a 40 mg vial for IV administration.

Part 2: Cohort 2a GSK2862277

Single IV dose of GSK2862277 as a continuous infusion over 1 hour.

Group Type EXPERIMENTAL

Single IV dose of GSK2862277

Intervention Type DRUG

GSK2862277 solution available in a 40 mg vial for IV administration.

Part 2: Cohort 2a Placebo

Matching placebo will be administered as a continuous IV infusion over 1 hour.

Group Type EXPERIMENTAL

Matching placebo single dose IV infusion

Intervention Type DRUG

Matching placebo solution available for IV administration.

Part 2: Cohort 2b GSK2862277

Single IH dose of GSK2862277.

Group Type EXPERIMENTAL

Single IH dose of GSK2862277

Intervention Type DRUG

GSK2862277 nebulised solution available in a 40 mg vial for IH administration.

Part 2: Cohort 2b Placebo

Matching placebo will be administered.

Group Type EXPERIMENTAL

Matching placebo single dose IH

Intervention Type DRUG

Matching placebo nebulised solution available for IH administration.

Part 3: Cohort 3a GSK2862277

IV dose of GSK2862277 (decided from Part 2) as a continuous infusion over 1 hour for daily 5 days.

Group Type EXPERIMENTAL

Repeat IV dose of GSK2862277

Intervention Type DRUG

GSK2862277 solution available in a 40 mg vial for IV administration.

Part 3: Cohort 3a Placebo

Matching placebo will be administered as IV infusion over 1 hour daily for 5 days.

Group Type EXPERIMENTAL

Matching placebo repeat dose IV infusion

Intervention Type DRUG

Matching placebo solution available for IV administration.

Part 3: Cohort 3b GSK2862277

Repeat IH dose of GSK2862277 (decided from Part 2) daily for 5 days.

Group Type EXPERIMENTAL

Repeat IH dose selected of GSK2862277 from Part 2

Intervention Type DRUG

GSK2862277 nebulised solution available in a 40 mg vial for IH administration.

Part 3: Cohort 3b Placebo

Matching placebo will be administered as IH daily for 5 days.

Group Type EXPERIMENTAL

Matching placebo repeat dose IH

Intervention Type DRUG

Matching placebo nebulised solution available for IH administration.

Interventions

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Single IV dose of GSK2862277

GSK2862277 solution available in a 40 mg vial for IV administration.

Intervention Type DRUG

Matching placebo single dose IV infusion

Matching placebo solution available for IV administration.

Intervention Type DRUG

Single IH dose of GSK2862277

GSK2862277 nebulised solution available in a 40 mg vial for IH administration.

Intervention Type DRUG

Matching placebo single dose IH

Matching placebo nebulised solution available for IH administration.

Intervention Type DRUG

Repeat IV dose of GSK2862277

GSK2862277 solution available in a 40 mg vial for IV administration.

Intervention Type DRUG

Matching placebo repeat dose IV infusion

Matching placebo solution available for IV administration.

Intervention Type DRUG

Repeat IH dose selected of GSK2862277 from Part 2

GSK2862277 nebulised solution available in a 40 mg vial for IH administration.

Intervention Type DRUG

Matching placebo repeat dose IH

Matching placebo nebulised solution available for IH administration.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Harrow, Middlesex, United Kingdom

Site Status

Countries

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United Kingdom

References

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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.

Reference Type DERIVED
PMID: 26178412 (View on PubMed)

Study Documents

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

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https://www.clinicalstudydatarequest.com

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Other Identifiers

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116343

Identifier Type: -

Identifier Source: org_study_id

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