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AsthmaPhase 1NCT00411814

A Study Of GSK679586A When Infused Into Healthy And Mild Asthmatic Volunteers

A Phase 1 study testing GSK679586 in people with Asthma, run by GlaxoSmithKline at 2 sites in Australia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This is a two part study. Part I is designed to test single doses of GSK678586A in healthy volunteers. Part II is designed to test repeat doses (two doses) of GSK679586A in patients with mild asthma. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Asthma
What is being tested?
GSK679586
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
56 participants
Where
2 sitesAustralia
Study dates
Nov 2006to Feb 2008
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Men aged 18 - 65 years inclusive, or women aged 18 - 50 years inclusive.
  • Female subjects must be of non-childbearing potential,
  • Male subjects must agree to abstain from sexual intercourse or use adequate contraception during sexual intercourse with pregnant or lactating females, in addition to their female partner using another form of contraception. This criterion must be followed from the time of the first dose of study medication until 84 days after the last dose of study medication.
  • Body weight ≥ 50 kg and BMI within the range 19 - 29.9 kg/m2.
  • Non-smoker as verified by urinary cotinine levels below 300 ng/mL at screening or ex-smokers who have given up smoking for >12 months with a history <10 pack years [Pack yrs = (No of cigarettes/day x No of years smoked)/20]
  • Available to complete all study measurements.
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  • Able to read, comprehend, and write English at a sufficient level to complete study related materials.
  • Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form
  • Additional Inclusion Criteria for Subjects in Part I
  • Healthy as determined by a responsible physician, based on a medical evaluation including history, physical examination, laboratory tests, cardiac monitoring.
  • Additional Inclusion Criteria for Subjects in Part II
  • History of asthma for at least 6 months prior to the screening visit currently requiring no treatment or intermittent treatment with inhaled short-acting beta2-agonist only. Subject must not have received low dose inhaled corticosteroids within three months prior to Day 0.
  • Pre-bronchodilator FEV1 >70% but <90% of predicted at screening with ≥12% reversibility after short-acting beta2-agonist or If the subject has a pre-bronchodilator FEV1 ≥90% at screening but has a history of asthma or if the subject meets the FEV1 criteria but does not demonstrate ≥12% reversibility after short-acting beta2-agonist administration, then the subject may be considered eligible if a Bronchial Provocation Test for asthma is positive (and after consultation with Medical Monitor and Principal Investigator). The bronchial provocation will be considered positive when the standard criteria for a positive response with the given challenge agent are met.
  • Skin prick test positive for an allergen that is appropriate for nasal challenge

Who cannot join

  • As a result of medical interview, physical examination or screening investigations, the responsible physician deemed the subject unsuitable for the study.
  • History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the physician responsible, contraindicates their participation.
  • Previous exposure to humanised antibody therapy for any reason.
  • A strong family history of Th1 cytokine-related inflammatory disorders, including but not limited to, Type I diabetes mellitus, multiple sclerosis, Crohn's disease, rheumatoid arthritis, sarcoidosis.
  • Known history of active or latent tuberculosis, or recent (within 6 months of study enrolment) exposure to a person with active tuberculosis. Previous medical history and letter from the subject's physician (GP) should exclude this.
  • A history of chronic urogenital infections or other chronic infections.
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  • Subjects who have received any type of vaccination in the last two months.
  • The subject has participated in a clinical trial and has received a drug or a new chemical entity within 30 days or 5 half-lives, or twice the duration of the biological effect of any drug(whichever is longer) prior to the first dose of current study medication
  • Where participation in study would result in donation of blood in excess of 500 mL within a 56 day period
  • Exposure to more than four new chemical entities within 12 months prior to the first dosing day
  • Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John'sWort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and sponsor the medication will not interfere with the study procedures or compromise subject safety.
  • History of alcohol/drug abuse or dependence within 12 months of the study:
  • Abuse of alcohol defined as an average weekly intake of greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine
  • A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening
  • A positive test for human immunodeficiency virus (HIV) antibodies.
  • The subject has a positive pre-study urine drug/ urine alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbiturates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
  • ECG that is outside of ranges as defined by the protocol
  • Those who, in the opinion of the Investigator, have a risk of non-compliance with study procedures.
  • The subject has a history of confirmed or active parasitic infection.
  • The subject is unable to refrain from travelling to countries with a high prevalence of infectious (especially parasitic) disease from when the first dose is administered until the expected washout period is complete (plasma levels below LLQ) or the last follow-up visit, which ever is later

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • GSK Investigational Site

    Melbourne, Victoria, 3004

  • GSK Investigational Site

    Randwick, New South Wales, 2031

Other trials in Australia

About this study

Official title: A Dose-escalating Study of the Safety and Pharmacokinetics of GSK679586A in Healthy Volunteers and Mild Asthmatics.

This is a two part study. Part I is designed to test single doses of GSK678586A in healthy volunteers. Part II is designed to test repeat doses (two doses) of GSK679586A in patients with mild asthma. Both parts are designed to investigate the safety, tolerability and the way the body absorbs GSK679586A when given by intravenous infusion (through a vein in your arm).

Conditions
Asthma
Being tested
GSK679586, Placebo
Keywords
melbourne,, healthy, antibody,, male,, Safety and pharmacokinetic study,, mild asthmatic patients,, australia, monoclonal, female,, volunteers,
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GSK679586Drug

    Active Drug

  • PlaceboDrug

    Also called Saline

    Saline

Study groups in NCT00411814
Study groupRoleWhat they receive
PlaceboPlacebo comparatorSaline
Receives: Drug: Placebo
ActiveActive comparatorGSK679586
Receives: Drug: GSK679586

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis

    Measured: Throughout the study

  2. Safety and tolerability in mild asthmatics.Assessed using clinical safety assessments and blood and urine analysis.

    Measured: Throughout the study

Secondary outcomes (5)

  1. Blood sampling

    Measured: Throughout the study

  2. Effects on blood and lung function.

    Measured: Throughout the study

  3. Lung function

    Measured: Throughout the study

  4. Plasma levels of GSK679586A to determine pharmacokinetic parameters

    Measured: Throughout the study

  5. serum antibodies to GSK679586A

    Measured: Throughout the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Dec 2006 (estimated)
  2. Study startNov 2006
  3. Primary completionFeb 2008
  4. Study completionFeb 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00411814
Sponsor's protocol ID
I13105054
Status last verified
Jan 2012
First submitted
14 Dec 2006
Last updated
19 Mar 2012
Results posted
No
Data monitoring committee
No

Publications

  • Hodsman P, Ashman C, Cahn A, De Boever E, Locantore N, Serone A, Pouliquen I. A phase 1, randomized, placebo-controlled, dose-escalation study of an anti-IL-13 monoclonal antibody in healthy subjects and mild asthmatics. Br J Clin Pharmacol. 2013 Jan;75(1):118-28. doi: 10.1111/j.1365-2125.2012.04334.x.

    PubMed 22616628

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GSK679586 in people with Asthma, run by GlaxoSmithKline at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability in healthy volunteers.Assessed using clinical safety assessments and blood and urine analysis (time frame: Throughout the study). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00411814, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.

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