Status:
COMPLETED
Safety and Tolerability Study of N6022 in Healthy Subjects
Lead Sponsor:
Nivalis Therapeutics, Inc.
Conditions:
Healthy
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy subjects.
Detailed Description
This is a single dose escalation, first-time-in-human study with three ascending cohorts. Eligible subjects will receive a single dose of investigational medicinal product or placebo on Day 1 and will...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT01147406
Start Date
August 1 2010
End Date
June 1 2011
Last Update
March 7 2014
Active Locations (1)
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1
Parexel Early Phase Unit
Baltimore, Maryland, United States, 21225