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NCT Number: NCT01563042

A Single Dose Pharmacokinetics (PK) Study of GSK2434735 in Healthy Male Volunteers

An exploratory First Time in Human (FTIH) study investigating the pharmacokinetics, immunogenicity, safety and tolerability of GSK2434735 administered as a single low dose in healthy male subjects

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site

Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom

About this study

Interleukin-13 (IL-13) and IL-4 are mediators in the pathogenesis of established asthmatic disease. GSK2434735 is a bispecific antibody to IL-13 and IL-4. The purpose of this open label, sequential cohort, exploratory First Time in Human (FTIH) study is to evaluate the pharmacokinetics (PK) profile of GSK2434735 after a single low intravenous or subcutaneous dose in healthy male volunteers, and to assess if the pharmacokinetics (PK) parameters can be scaled from monkey to man. In addition, the safety and tolerability will be monitored and the study will assess if antibodies are generated to GSK2434735.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male volunteers between 18 and 65 years of age
  • Negative for pre-existing antibodies to GSK2434735.
  • Body weight greater than and equal to 50 kg
  • BMI 19 - 29.9 kg/m2.
  • Lifelong non-smokers or ex-smokers of greater than 6 months

Exclusion criteria

  • Clinically significant abnormalities.
  • Current or past history of significant cardiac, respiratory, metabolic, renal, hepatic, neurological or gastrointestinal conditions.
  • Current evidence or recent history of an infective illness.
  • Vaccination within 3 weeks of screening
  • History of severe allergic reactions, angio-oedema, anaphylaxis or immunodeficiency

Treatment and study plan

Intravenous (IV) single dose

Drug

GSK2434735 administered as a single intervenous dose at the beginning of the study

Other names: GSK2434735

Subcutaneous (SC) single dose

Drug

GSK2434735 administered as a single subcutaneous dose at the beginning of the study

Other names: GSK2434735

Primary outcomes

  1. Profile of Pharmacokinetics

    Time frame: 42 days

    Cmax, tmax, AUC, CL, t1/2

Secondary outcomes

  1. Safety and tolerability of GSK2434735 as assessed by telemetry and change from baseline in 12-lead Electrocardiograms (ECG)

    Time frame: 42 days

    Change from baseline for PR, RR, QRS, QT, QTc measurements at Day 42

  2. Safety and tolerability of GSK2434735 as assessed by change from baseline in blood pressure and heart rate

    Time frame: 42 days

    Change from baseline for systolic and diastolic blood pressure and heart rate measurements at 42 Days

  3. Safety and tolerability of GSK2434735 as assessed by number of participants with adverse events

    Time frame: 42 days

    Clinically relevant changes from baseline in subject's disposition at Day 42

  4. Change from baseline for Clinical laboratory assessments (hematology, chemistry and urinalysis

    Time frame: 42 days

    Changes from baseline values of hematologic , chemistry and urinary testing parameters at Day 42

  5. Assessment of human anti-drug antibodies (ADA) in blood

    Time frame: 42 days

    Incidence of human anti-drug antibodies (ADA) at Day 42

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

An Exploratory First Time in Human (FTIH) Study Investigating the Pharmacokinetics (PK), Immunogenicity, Safety and Tolerability of GSK2434735 Administered as a Single Low Dose in Healthy Male Subjects

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Mar 26, 2012
Registry last updated
Jun 20, 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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