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Safety and Tolerability Study of N6022 in Healthy Subjects

NCT01147406 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 41

Last updated 2014-03-07

Study results available
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Summary

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

Conditions

  • Healthy

Interventions

DRUG

N6022

This is an injectible formulation which will be given at 5, 15 \& 45 mg over 1, 3 and 9 minutes respectively, in single ascending doses.

DRUG

Placebo

This will be 0.9% normal saline given over 1, 3, or 9 minutes IV bolus.

Sponsors & Collaborators

  • Nivalis Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Ronald Goldwater, MDCM, MSc(A) · Parexel

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-06-30
Completion
2011-06-30

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01147406 on ClinicalTrials.gov