Clinical trial NCT01563042: A Single Dose Pharmacokinetics (PK) Study of GSK2434735 in Healthy Male Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Asthma
Keywords: immunogenicity
GSK2434735
pharmacokinetics (PK)
PK
biospecific antibody
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-03-26
Enrollment: 5
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Profile of Pharmacokinetics
timeFrame: 42 days
Secondary outcomes:
measure: Safety and tolerability of GSK2434735 as assessed by telemetry and change from baseline in 12-lead Electrocardiograms (ECG)
timeFrame: 42 days
measure: Safety and tolerability of GSK2434735 as assessed by change from baseline in blood pressure and heart rate
timeFrame: 42 days
measure: Safety and tolerability of GSK2434735 as assessed by number of participants with adverse events
timeFrame: 42 days
measure: Change from baseline for Clinical laboratory assessments (hematology, chemistry and urinalysis
timeFrame: 42 days
measure: Assessment of human anti-drug antibodies (ADA) in blood
timeFrame: 42 days
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: GSK Investigational Site
state: Cambridgeshire
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: