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

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

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Intravenous (IV) single dose; Drug: Subcutaneous (SC) single dose

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: GSK2434735

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Profile of Pharmacokinetics	Cmax, tmax, AUC, CL, t1/2	42 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Assessment of human anti-drug antibodies (ADA) in blood	Incidence of human anti-drug antibodies (ADA) at Day 42	42 days

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

Helpful 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2012
• Primary Completion (Actual): May 23, 2012
• Study Completion (Actual): May 23, 2012

Study Registration Dates

• First Submitted: March 15, 2012
• First Submitted That Met QC Criteria: March 22, 2012
• First Posted (Estimate): March 26, 2012

Study Record Updates

• Last Update Posted (Actual): June 20, 2017
• Last Update Submitted That Met QC Criteria: June 19, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Keywords: pharmacokinetics (PK); PK; immunogenicity; GSK2434735; biospecific antibody
• Other Study ID Numbers: 114594

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Study Protocol
   Information identifier: 114594
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Clinical Study Report
   Information identifier: 114594
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Statistical Analysis Plan
   Information identifier: 114594
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 114594
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Individual Participant Data Set
   Information identifier: 114594
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Informed Consent Form
   Information identifier: 114594
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Annotated Case Report Form
   Information identifier: 114594
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register