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

GlaxoSmithKline5 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Asthma

Interventions

Intravenous (IV) single doseDRUG

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

Subcutaneous (SC) single doseDRUG

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

Eligibility

Sex: MALEMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

GSK Investigational Site

Cambridge, Cambridgeshire, United Kingdom

Outcomes

Primary Outcomes

Profile of Pharmacokinetics

Cmax, tmax, AUC, CL, t1/2

Time frame: 42 days

Secondary Outcomes

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

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

Time frame: 42 days

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

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

Time frame: 42 days

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

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

Time frame: 42 days

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

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

Time frame: 42 days

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

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

Time frame: 42 days

Data from ClinicalTrials.gov

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