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

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ClinicalTrials.gov Identifier: NCT01563042

Recruitment Status : Completed

First Posted : March 26, 2012

Last Update Posted : June 20, 2017

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

Study Description

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

Condition or disease	Intervention/treatment	Phase
Asthma	Drug: Intravenous (IV) single dose Drug: Subcutaneous (SC) single dose	Phase 1

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	5 participants
Allocation:	Non-Randomized
Intervention Model:	Parallel Assignment
Masking:	None (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
Actual Study Start Date :	February 13, 2012
Actual Primary Completion Date :	May 23, 2012
Actual Study Completion Date :	May 23, 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

Profile of Pharmacokinetics [ Time Frame: 42 days ]
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 ]
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 ]
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 ]
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 ]
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 ]
Incidence of human anti-drug antibodies (ADA) at Day 42

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 65 Years (Adult, Older Adult)
Sexes 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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01563042

Locations

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United Kingdom
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ

Sponsors and Collaborators

GlaxoSmithKline

Investigators

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Study Director:	GSK Clinical Trials	GlaxoSmithKline

More Information

Additional Information:

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