Phase 1 N=41 Randomized Quadruple-blind Treatment

Safety and Tolerability Study of N6022 in Healthy Subjects

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01147406 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2014

Primary outcome: Primary: Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers — 1; 4; 1; 0 Adverse Events

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: N6022 (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: Nivalis Therapeutics, Inc.
Primary completion: Jun 2011

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	—

Summary

The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy subjects.

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

View full record on ClinicalTrials.gov →

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.