Last updated: 11/07/2018 07:58:34
A single dose pharmacokinetics (PK) study of GSK2434735 in healthy male volunteers
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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
Trial description: 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
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Profile of Pharmacokinetics
Timeframe: 42 days
Secondary outcomes:
Safety and tolerability of GSK2434735 as assessed by telemetry and change from baseline in 12-lead Electrocardiograms (ECG)
Timeframe: 42 days
Safety and tolerability of GSK2434735 as assessed by change from baseline in blood pressure and heart rate
Timeframe: 42 days
Safety and tolerability of GSK2434735 as assessed by number of participants with adverse events
Timeframe: 42 days
Change from baseline for Clinical laboratory assessments (hematology, chemistry and urinalysis
Timeframe: 42 days
Assessment of human anti-drug antibodies (ADA) in blood
Timeframe: 42 days
Interventions:
Drug: Intravenous (IV) single dose
Drug: Subcutaneous (SC) single dose
Enrollment:
5
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Claire Ashman, Isabelle Pouliquen,. An investigation of the pharmacokinetics of a novel bi-specific antibody in an exploratory FTIH study. American Association of Pharmaceutical Scientists - 2013 National Biotechnology Conference. 2013
Medical condition
Asthma
Product
GSK2434735
Collaborators
Not applicable
Study date(s)
February 2012 to May 2012
Type
Interventional
Phase
1
Participation criteria
Sex
Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
- Healthy male volunteers between 18 and 65 years of age
- Negative for pre-existing antibodies to GSK2434735.
- Clinically significant abnormalities.
- Current or past history of significant cardiac, respiratory, metabolic, renal, hepatic, neurological or gastrointestinal conditions.
Inclusion and exclusion 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
Trial location(s)
Location
GSK Investigational Site
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2012-23-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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