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

Phase 1

Completed

• Conditions: Asthma
• Interventions: Drug: Intravenous (IV) single dose; Drug: Subcutaneous (SC) single dose

• Registration Number: NCT01563042
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-02-13
• Study First Submitted: 2012-03-15
• Study First Submitted QC: 2012-03-22
• Study First Posted: 2012-03-26
• Primary Completion: 2012-05-23
• Study Completion: 2012-05-23
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-19
• Last Update Posted: 2017-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1 GSK2434735	Intravenous (IV) single dose	Cohort 1: Single intravenous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose.
Cohort 2 GSK2434735	Subcutaneous (SC) single dose	Cohort 2: Single subcutaneous administration of GSK2434735 and Pharmacokinetic (PK) and Immunogenicity assessments up to 42 days post dose.

Primary Outcome Measures

Name	Time	Method
Profile of Pharmacokinetics	42 days	Cmax, tmax, AUC, CL, t1/2

Secondary Outcome Measures

Name	Time	Method
Assessment of human anti-drug antibodies (ADA) in blood	42 days	Incidence of human anti-drug antibodies (ADA) at Day 42
Safety and tolerability of GSK2434735 as assessed by number of participants with adverse events	42 days	Clinically relevant changes from baseline in subject's disposition at Day 42
Safety and tolerability of GSK2434735 as assessed by telemetry and change from baseline in 12-lead Electrocardiograms (ECG)	42 days	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	42 days	Change from baseline for systolic and diastolic blood pressure and heart rate measurements at 42 Days
Change from baseline for Clinical laboratory assessments (hematology, chemistry and urinalysis	42 days	Changes from baseline values of hematologic , chemistry and urinary testing parameters at Day 42

Trial Locations

Locations (1)

GSK Investigational Site; 🇬🇧 Cambridge, Cambridgeshire, United Kingdom