A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects
Completed · Phase 1 · Has a placebo group
Conditions studied: Healthy
In brief
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.
Key facts
- Study ID
- NCT01339897
- Run by
- Nivalis Therapeutics, Inc.
- People needed
- 25
- Starts
- 2011-04-01
- Expected to finish
- 2011-08-01
- Last updated by the study team
- 2015-01-19
Who can join
Age: 18 and older, up to 45. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Subject is healthy, determined by pre-study medical evaluation (medical history, physical examination, vital signs, 12-lead ECG, and clinical laboratory evaluations
- 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.
- Subject has a body weight > 50 kg and BMI between 19.5 and 29.5 kg/m2, inclusive, at screening.
- Subject has systolic BP > 90 mmHg and diastolic BP > 50 mmHg at screening or Day-1.
You may not qualify if…
- 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.
- Subject is a current alcohol abuser and/or has a history of illicit drug abuse within six months of entry.
- Subject has donated blood (> 500 mL) or blood products within 56 days prior to Day -1.
- Subject has a history of bleeding disorders (i.e., severe hemorrhage, melena, rectal bleeding, nosebleeds, bruising, etc.).
Where it is running
- Parexel International — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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