Phase 1
Completed N=41
Safety and Tolerability Study of N6022 in Healthy Subjects
Healthy
Source: ClinicalTrials.gov NCT01147406 ↗
Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers — 1; 4; 1; 0 Adverse Events
Summary
The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy subjects.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers |
1; 4; 1; 0; 1; 2 | — |
| SECONDARY Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration |
311; 1570; 1590; 3330; 4030; 0 | — |
Eligibility Criteria
Inclusion:
- Subject is healthy
Exclusion:
- 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
Data sourced from ClinicalTrials.gov (NCT01147406). 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.