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

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

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-13

Study Completion Date

2012-05-23

Brief Summary

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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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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Cohort 1 GSK2434735

Cohort 1: Single intravenous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose.

Group Type EXPERIMENTAL

Intravenous (IV) single dose

Intervention Type DRUG

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

Cohort 2 GSK2434735

Cohort 2: Single subcutaneous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose.

Group Type EXPERIMENTAL

Subcutaneous (SC) single dose

Intervention Type DRUG

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

Interventions

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Intravenous (IV) single dose

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

Intervention Type DRUG

Subcutaneous (SC) single dose

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

Intervention Type DRUG

Other Intervention Names

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GSK2434735 GSK2434735

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

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

Cambridge, Cambridgeshire, United Kingdom

Site Status

Countries

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United Kingdom

Study Documents

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