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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Asthma

Treatments: Drug: Intravenous (IV) single dose; Drug: Subcutaneous (SC) single dose

Study type: Interventional

Funder types: Industry

Identifiers

NCT01563042

114594

Details and patient eligibility

About

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

Full 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.

Enrollment: 5 patients

Sex: Male

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5 participants in 2 patient groups

Cohort 1 GSK2434735

Experimental group

Description:

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

Treatment:

Drug: Intravenous (IV) single dose

Cohort 2 GSK2434735

Experimental group

Description:

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

Treatment:

Drug: Subcutaneous (SC) single dose