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Completed

NCT Number: NCT01818024

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

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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Key information

Conditions

Respiratory Disorders Lung Diseases Lung Injury Respiration Disorders Respiratory Tract Diseases Thoracic Injuries Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Harrow, Middlesex, HA13UJ, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single IV dose of GSK2862277

Drug

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

Matching placebo single dose IV infusion

Drug

Matching placebo solution available for IV administration.

Single IH dose of GSK2862277

Drug

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

Matching placebo single dose IH

Drug

Matching placebo nebulised solution available for IH administration.

Repeat IV dose of GSK2862277

Drug

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

Matching placebo repeat dose IV infusion

Drug

Matching placebo solution available for IV administration.

Repeat IH dose selected of GSK2862277 from Part 2

Drug

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

Matching placebo repeat dose IH

Drug

Matching placebo nebulised solution available for IH administration.

Primary outcomes

  1. Safety and tolerability of single IV or IH dose of GSK2862277 assessed by number of subjects with adverse events (AE)s in Part 1 and Part 2

    Time frame: Up to 42 days

    Safety and tolerability parameters will include recording of adverse events (AEs), throughout the study.

  2. Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by number of subjects with AEs in Part 3

    Time frame: Up to 42 days

    Safety and tolerability parameters will include recording of AEs, throughout the study.

  3. Safety and tolerability of single IV or IH dose of GSK2862277 assessed by laboratory tests in Part 1 and Part 2

    Time frame: Up to 42 days

    Laboratory tests will include haemogram, clinical chemistry, urine examination.

  4. Safety and tolerability of repeat IV or IH dose of GSK2862277 as assessed by laboratory tests in Part 3

    Time frame: Up to 42 days

    Laboratory tests will include haemogram, clinical chemistry, urine examination.

  5. Safety and tolerability of single IV or IH dose of GSK2862277 assessed by vital signs in Part 1 and Part 2

    Time frame: Up to 42 days

    Vital signs will include blood pressure (BP), heart rate respiration rate and body temperature.

  6. Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by vital signs in Part 3

    Time frame: Up to 42 days

    Vital signs will include BP, heart rate respiration rate and body temperature.

  7. Safety and tolerability of single IV or IH dose of GSK2862277 assessed by ECG in Part 1 and Part 2

    Time frame: Up to 42 days

    Safety data will include electrocardiogram (ECG) readings obtained at each timepoint during the study.

  8. Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by ECG in Part 3

    Time frame: Up to 42 days

    Safety data will include ECG readings obtained at each timepoint during the study.

  9. Safety and tolerability of single IV or IH dose of GSK2862277 assessed by spirometry monitoring in Part 1 and Part 2

    Time frame: Up to 42 days

    Spirometry monitoring will include forced expiratory volume in one second (FEV1) and forced vital capacity (FVC).

  10. Safety and tolerability of repeat IV or IH dose of GSK2862277 assessed by spirometry monitoring in Part 3

    Time frame: Up to 42 days

    Spirometry monitoring will include FEV1 and FVC.

  11. Safety and tolerability of single IV dose of GSK2862277 as assessed by measurement of plasma cytokines in Part 1

    Time frame: Up to 42 days

    Blood samples will be collected for assessment of plasma cytokines.

  12. Immunogenicity in subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2

    Time frame: Up to 60 days

    Presence of anti GSK2862277 binding antibodies will be evaluated.

  13. Immunogenicity in subjects receiving repeat IV or IH dose of GSK2862277 in Part 3

    Time frame: Up to 60 days

    Presence of anti GSK2862277 binding antibodies will be evaluated.

Secondary outcomes

  1. Pharmacokinetic (PK) parameters in subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2

    Time frame: Up to 48 hours post dose

    The blood samples will be collected for plasma concentrations of GSK2862277.

  2. PK parameters in subjects receiving repeat IV dose of GSK2862277 in Part 3 Cohort 3a

    Time frame: Up to 48 hours post last dose

    The blood samples will be collected for plasma concentrations of GSK2862277.

  3. PK parameters in subjects receiving repeat IH dose of GSK2862277 in Part 3 Cohort 3b

    Time frame: Up to 48 hours post last dose

    The blood samples will be collected for plasma concentrations of GSK2862277

  4. PK parameters in subjects receiving single IV dose of GSK2862277 in Part 1

    Time frame: Up to 48 hours post last dose

    The PK parameters will be compared with historic GSK1995057 PK data in Part 1

  5. Pharmacodynamic and immune function biomarkers in serum of subjects receiving single IV or IH dose of GSK2862277 in Part 1 and Part 2

    Time frame: Up to 48 hours post last dose

    The pharmacodynamic and immune function biomarkers in serum.

  6. Pharmacodynamic and immune function biomarkers in serum of subjects receiving repeat IV or IH dose of GSK2862277in Part 3

    Time frame: Up to 48 hours post last dose

    The pharmacodynamic and immune function biomarkers in serum.

  7. Change from baseline in IL-8 expression in ex vivo WBA in subjects receiving single IV 0.05 mg/kg dose of GSK2862277 in Part 1 in Cohort1c

    Time frame: Up to 12 hours post dose

    IL-8 expression in ex vivo whole blood essay (WBA).

  8. Composite of urine parameters in subjects receiving single IV 2 mg/kg dose of GSK2862277 in Part 2 in Cohort 2a

    Time frame: Up to 48 hours post dose

    The urine samples will be collected for urine concentrations of GSK2862277.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

A Three Part, Randomised, Placebo-controlled Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Repeat Doses of Inhaled and Intravenous GSK2862277 in Healthy Volunteers

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Mar 26, 2013
Registry last updated
May 15, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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