Expired Study
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Baltimore, Maryland 21225


Purpose:

This Phase 1 study will evaluate multiple doses across a range that has been found to be effective in mouse models of asthma and safe in one Phase 1 clinical trial. It is intended to provide evidence of the tolerability of multiple doses as well as provide information on the Pharmacokinetic (PK) and metabolism of N6022 in humans.


Criteria:

Inclusion Criteria: 1. Subject is healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations 2. Subject is a non-smoker (or other nicotine user) as determined by history (no nicotine use over the past year) and a negative urine cotinine test at screening and Day 1. 3. Subject has a body weight > 50 kg and BMI between 19.5 and 29.5 kg/m2, inclusive, at screening. 4. Subject has systolic BP > 90 mmHg and diastolic BP > 50 mmHg at screening or Day-1. Exclusion Criteria: 1. Subject has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the investigator or designee. 2. Subject is a current alcohol abuser and/or has a history of illicit drug abuse within six months of entry. 3. Subject has donated blood (> 500 mL) or blood products within 56 days prior to Day -1. 4. Subject has a history of bleeding disorders (i.e., severe hemorrhage, melena, rectal bleeding, nosebleeds, bruising, etc.).


NCT ID:

NCT01339897


Primary Contact:

Principal Investigator
Ronald Goldwater, MDCM, MSc(A)
PAREXEL International


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21225
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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