CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 25 enrolled
Drug / intervention
5 mg/N6022 +3 moredrug
Likely dose
5 mg/N6022from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01339897
NCT01339897Phase 1Completed
CompareCT.gov

A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Multiple-Ascending Dose Study Evaluating the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Effects of N6022 in Healthy Subjects

Nivalis Therapeutics, Inc.·interventional·Posted Apr 21, 2011·Updated Jan 19, 2015

In Brief

A Phase 1 clinical trial evaluating 5 mg/N6022, Placebo, and 2 other interventions for Healthy. Completed, enrolled 25 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 21, 2011
Enrollment StartApr 1, 2011
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 15.2 years ago

Interventions

5 mg/N6022drug

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

Placebodrug

Same administration procedures as active

10mg/N6022drug

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

20mg/N6022drug

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