A Phase I study to evaluate the safety, tolerability and pharmacodynamics of inhaled Leukotriene B4 (LTB4) in healthy subjects and in chronically infected bronchiectasis patients

TB4 Sweden AB0 sites30 target enrollmentNovember 14, 2014

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Not specified
Sponsor: TB4 Sweden AB
Enrollment: 30
Status: Completed
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 14, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

TB4 Sweden AB

Eligibility Criteria

Inclusion Criteria

•PART A – INCLUSION CRITERIA
•1\. Males or females 18 – 70 years of age (inclusive).
•2\.Able to communicate with site personnel and to understand and voluntarily sign the Informed Consent Form.
•3\.Willing and able to comply with the Protocol, including availability for all scheduled study visits.
•4\.Use of effective contraception (A highly effective method of birth control is defined as those which result in a low failure rate(i.e. less than 1 percent per year) when used consistently and correctly), if procreative potential exists.
•5\.Body Mass Index (BMI) of 18 to 30 kg/m2 inclusive and weight up to a maximum of 90 kg inclusive.
•6\.Negative urine screen for drugs of abuse and negative alcohol breath test at screening and prior to dosing.
•7\.In good general health with no clinically significant abnormalities at screening determined by medical history, vital signs, physical examination, serum chemistry, hematology, urinalysis, and 12\-lead ECG.
•PART B – INCLUSION CRITERIA
•2\.Males or females 18 \- 75 years of age (inclusive) with a clinical diagnosis of bronchiectasis.

Exclusion Criteria

•PART A – EXCLUSION CRITERIA
•1\.Participation in another experimental/interventional protocol within 30 days prior to screening.
•2\.Females who are nursing, pregnant or intend to become pregnant or females of childbearing potential who have had a positive pregnancy test during screening evaluation.
•3\.A history of drug or alcohol abuse within one year of study entry. Alcohol abuse is defined as consumption of more than 3 standard drinks per day and not able to abstain from alcohol totally within 24 hours of dose administration until the end of the treatment period.
•4\.Positive human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) and tuberculosis (TB) screening test results.
•5\.Smokers (ex\-smokers who quit smoking must have a one year period of not smoking prior to the Investigational Product administration).
•6\.Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
•7\.Donation of blood or plasma within one month of Investigational Product administration.
•8\.Subjects who in the opinion of the Investigator are in poor medical or psychiatric risk for therapy with an investigational drug.
•9\.History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past five years, regardless of whether there is evidence of local recurrence or metastases.