Safety Study of GSK1995057 Given as Single and Repeat Intravenous Doses in Healthy Subjects.

NCT ID: NCT01476046

Last Updated: 2017-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-03-08
• Study Completion Date: 2012-06-17

Brief Summary

The main purpose of the study is to see how safe GSK1995057 is and how well it is tolerated after dosing. The study will also investigate how GSK1995057 is taken up, metabolised (chemically broken down), distributed through the body and excreted, and what some of the effects of the study drug are.

Detailed Description

This study will be the first investigation of GSK1995057 in humans and is primarily designed to investigate safety and tolerability of single and repeat intravenously infused doses. The study will enrol healthy male subjects and healthy female subjects of non-child bearing potential and will also investigate immunogenicity, GSK1995057 distribution (pharmacokinetics), and potential impact on indicators of host immunity and normal immunological function. Safety, tolerability, immunogenicity, pharmacokinetic and pharmacodynamic data from this trial may facilitate further clinical investigations in healthy subjects dosed with GSK1995057 via the inhaled route, and ultimately clinical trials in patients with acute lung injury.

Conditions

Respiratory Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

GSK1995057

Single intravenous dose

Group Type: EXPERIMENTAL

GSK1995057 single dose

Intervention Type: DRUG

Single intravenous dose

Placebo

Single intravenous dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Single intravenous dose

Interventions

GSK1995057 single dose

Single intravenous dose

Intervention Type: DRUG

Placebo

Single intravenous dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy as determined by a responsible and experienced physician.
• Male or female between 18 and 55 years of age inclusive
• A female subject is eligible to participate if she is of non-childbearing potential defined as pre-menopausal females with a documented tubal ligation, hysterectomy or bilateral oophorectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea and elevated FSH as per the local laboratory guidelines.
• Normal creatinine clearance values at screening
• Male subjects must agree to use one of the study specific contraception methods
• Body weight ≥ 50 kg and BMI within the range 19 - 29.9 kg/m2 (inclusive).
• Normal lung function at screening.
• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
• Available to complete all study assessments.
• Able to read, comprehend and write English at a sufficient level to complete study elated materials.

Exclusion Criteria

• A history of Hepatitis B, Hepatitis C or HIV infection and/or a positive pre-study HIV, Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities. (With the exception of known Gilbert's syndrome or asymptomatic gallstones).
• A positive pre-study drug/alcohol screen.
• Evidence of previous or active mycobacterium tuberculosis complex infection
• Recent history of and/or a positive test for Toxoplasma consistent with active oxoplasmosis infection.
• A positive test for influenza A/B taken within 7 days before dosing.
• Current evidence or history of an influenza-like illness.
• Corrected QT interval (QTcF) >450msec from ECG readings.
• History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol and the following can be used as a guide: a half-pint (~240 ml) of beer, 1 glass (125 ml) of wine or 1 (25 ml) measure of spirits.
• The subject is unwilling to abstain from alcohol consumption from 24 hr prior to dosing until discharge from the clinic, and for 24 hr prior to all other out-patient clinic visits.
• Subjects with a smoking history of >10 cigarettes per day in the last 3 months.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) or exposure to more than four new chemical or biological entities within 12 months prior to the first dosing day.
• Subjects having received any type of vaccination within 3 weeks of the anticipated dosing start or are expected to be vaccinated within 3 weeks after the last dose.
• Current evidence of ongoing or acute infection, history of repeated or chronic significant infections or history of serious infection within three months of dosing.
• Subjects who have asthma or a history of asthma, COPD, other respiratory conditions or recurrent infections (a subject who suffered from childhood asthma but not as an adult may be included provided they fulfil other entry criteria).
• Subjects who have a known history of migraine headaches or are frequently suffering from other types of headaches which require medication (frequent defined as more than one headache in a fortnight).
• Use of prescription or non-prescription drugs (except simple analgesics), including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsors Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
• History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy including severe allergic reaction, angio-edema or anaphylaxis that, in the opinion of the investigator or sponsors Medical Monitor, contraindicates their participation.
• History of malignancy, except for adequately treated non-invasive cancer of the skin (basal or squamous cell) or cervical carcinoma in situ (>2 yrs prior to dosing).
• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 3 month or 90 day period.
• Subject is unable to refrain from travelling to countries with a high prevalence of TB or other areas of prevalent infectious disease as judged by the investigator or the sponsors medical monitor from the start of screening until the final follow-up visit.
• Subject is mentally or legally incapacitated.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Harrow, Middlesex, United Kingdom

Countries

United Kingdom

Study Documents

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

110951

Identifier Type: -

Identifier Source: org_study_id