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

Launched by GLAXOSMITHKLINE · Mar 22, 2012

Keywords

ClinConnect Summary

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...

Gender

MALE

Eligibility 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