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A Safety Study Evaluating N6022 in Multiple-Ascending Doses in Healthy Subjects

NCT01339897 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2015-01-19

Study results available
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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.

Conditions

  • Healthy

Interventions

DRUG

5 mg/N6022

Intravenous formulation, given at doses of 5 mg once each day over 7 days.

DRUG

Placebo

Same administration procedures as active

DRUG

10mg/N6022

Intravenous formulation given at doses of 10 mg once each day over 7 days.

DRUG

20mg/N6022

Intravenous formulation given at doses of 20 mg once each day over 7 days.

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
2011-04-30
Primary Completion
2011-08-31
Completion
2011-08-31

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 NCT01339897 on ClinicalTrials.gov