A Single Dose Pharmacokinetics (PK) Study of GSK2434735 in Healthy Male Volunteers
This study has been completed.
Sponsor:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01563042
First received: March 15, 2012
Last updated: May 31, 2012
Last verified: May 2012
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Intravenous (IV) single dose Drug: Subcutaneous (SC) single dose |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science |
| 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 |
Resource links provided by NLM:
Further study details as provided by GlaxoSmithKline:
Primary Outcome Measures:
- Profile of Pharmacokinetics [ Time Frame: 42 days ] [ Designated as safety issue: No ]Cmax, tmax, AUC, CL, t1/2
Secondary Outcome Measures:
- Safety and tolerability of GSK2434735 as assessed by telemetry and change from baseline in 12-lead Electrocardiograms (ECG) [ Time Frame: 42 days ] [ Designated as safety issue: No ]Change from baseline for PR, RR, QRS, QT, QTc measurements at Day 42
- Safety and tolerability of GSK2434735 as assessed by change from baseline in blood pressure and heart rate [ Time Frame: 42 days ] [ Designated as safety issue: No ]Change from baseline for systolic and diastolic blood pressure and heart rate measurements at 42 Days
- Safety and tolerability of GSK2434735 as assessed by number of participants with adverse events [ Time Frame: 42 days ] [ Designated as safety issue: No ]Clinically relevant changes from baseline in subject's disposition at Day 42
- Change from baseline for Clinical laboratory assessments (hematology, chemistry and urinalysis [ Time Frame: 42 days ] [ Designated as safety issue: No ]Changes from baseline values of hematologic , chemistry and urinary testing parameters at Day 42
- Assessment of human anti-drug antibodies (ADA) in blood [ Time Frame: 42 days ] [ Designated as safety issue: No ]Incidence of human anti-drug antibodies (ADA) at Day 42
| Enrollment: | 5 |
| Study Start Date: | February 2012 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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 Name: 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 Name: GSK2434735
|
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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations More Information
No publications provided
| Responsible Party: | GlaxoSmithKline |
| ClinicalTrials.gov Identifier: | NCT01563042 History of Changes |
| Other Study ID Numbers: | 114594 |
| Study First Received: | March 15, 2012 |
| Last Updated: | May 31, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Keywords provided by GlaxoSmithKline:
|
immunogenicity GSK2434735 pharmacokinetics (PK) PK biospecific antibody |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013