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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01563042
First received: March 15, 2012
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Intravenous (IV) single dose
Drug: Subcutaneous (SC) single dose
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Profile of Pharmacokinetics [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Cmax, tmax, AUC, CL, t1/2


Secondary Outcome Measures:
  • Safety and tolerability of GSK2434735 as assessed by telemetry and change from baseline in 12-lead Electrocardiograms (ECG) [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Change from baseline for PR, RR, QRS, QT, QTc measurements at Day 42

  • Safety and tolerability of GSK2434735 as assessed by change from baseline in blood pressure and heart rate [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Change from baseline for systolic and diastolic blood pressure and heart rate measurements at 42 Days

  • Safety and tolerability of GSK2434735 as assessed by number of participants with adverse events [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Clinically relevant changes from baseline in subject's disposition at Day 42

  • Change from baseline for Clinical laboratory assessments (hematology, chemistry and urinalysis [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Changes from baseline values of hematologic , chemistry and urinary testing parameters at Day 42

  • Assessment of human anti-drug antibodies (ADA) in blood [ Time Frame: 42 days ] [ Designated as safety issue: No ]
    Incidence of human anti-drug antibodies (ADA) at Day 42


Enrollment: 5
Study Start Date: February 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohort 1 GSK2434735
Cohort 1: Single intravenous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose.
Drug: Intravenous (IV) single dose
GSK2434735 administered as a single intervenous dose at the beginning of the study
Other Name: GSK2434735
Experimental: Cohort 2 GSK2434735
Cohort 2: Single subcutaneous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose.
Drug: Subcutaneous (SC) single dose
GSK2434735 administered as a single subcutaneous dose at the beginning of the study
Other Name: GSK2434735

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01563042

Locations
United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01563042     History of Changes
Other Study ID Numbers: 114594
Study First Received: March 15, 2012
Last Updated: May 31, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
immunogenicity
GSK2434735
pharmacokinetics (PK)
PK
biospecific antibody

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 26, 2014