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

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01563042
• Other study ID #: 114594
• Status: Completed
• Phase: Phase 1
• First received: March 15, 2012
• Last updated: June 19, 2017
• Start date: February 13, 2012
• Est. completion date: May 23, 2012

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: May 23, 2012
• Est. primary completion date: May 23, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Intravenous (IV) single dose
GSK2434735 administered as a single intervenous dose at the beginning of the study
• Subcutaneous (SC) single dose
GSK2434735 administered as a single subcutaneous dose at the beginning of the study

Locations

Country	Name	City	State
United Kingdom	GSK Investigational Site	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Profile of Pharmacokinetics	Cmax, tmax, AUC, CL, t1/2	42 days
Secondary	Safety and tolerability of GSK2434735 as assessed by telemetry and change from baseline in 12-lead Electrocardiograms (ECG)	Change from baseline for PR, RR, QRS, QT, QTc measurements at Day 42	42 days
Secondary	Safety and tolerability of GSK2434735 as assessed by change from baseline in blood pressure and heart rate	Change from baseline for systolic and diastolic blood pressure and heart rate measurements at 42 Days	42 days
Secondary	Safety and tolerability of GSK2434735 as assessed by number of participants with adverse events	Clinically relevant changes from baseline in subject's disposition at Day 42	42 days
Secondary	Change from baseline for Clinical laboratory assessments (hematology, chemistry and urinalysis	Changes from baseline values of hematologic , chemistry and urinary testing parameters at Day 42	42 days
Secondary	Assessment of human anti-drug antibodies (ADA) in blood	Incidence of human anti-drug antibodies (ADA) at Day 42	42 days

External Links

•   Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
•   Results for study 114594 can be found on the GSK Clinical Study Register.