Phase 1
Completed N=25
A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT01339897 ↗
Enrolled (actual)
25
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcomePrimary: Safety of Escalating Multiple Doses of N6022 in Healthy Subjects — 7; 6; 6; 6 participants
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety of Escalating Multiple Doses of N6022 in Healthy Subjects |
7; 6; 6; 6; 1; 0 | — |
| SECONDARY Pharmacokinetics of N6022 |
138; 334; 669; 0 | — |
| SECONDARY Pharmacokinetics of N6022 Over 7 Days |
149; 367; 811; 0 | — |
| SECONDARY Pharmacokinetics of N6022 on Study Day 1 |
465; 1270; 1400; 0 | — |
| SECONDARY Pharmacokinetics of N6022 Cmax Values on Study Day 7 |
287; 1110; 2320; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.).
Data sourced from ClinicalTrials.gov (NCT01339897). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.