Safety and Tolerability Study of N6022 in Healthy Subjects

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: N6022; Drug: Placebo

• Registration Number: NCT01147406
• Lead Sponsor: Nivalis Therapeutics, Inc.

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 be followed for safety, PK, and PD for 72 hours post dose. Follow-up visits on Day 4 and Day 7 for the end-of-study safety. Participation of an individual subject may last up to 36 days from the time of screening until the end-of-study follow-up visit. Each cohort will enroll a sentinel pair (1:1 randomized to active: placebo). These subjects will be followed for 48 hours postdose and safety data reviewed before the remaining subjects in the cohort receive IMP. A Safety Monitoring Committee will review the seven-day safety data in each cohort before proceeding to the next ascending dose cohort, according to the stopping rules outlined in the protocol.

Study Timeline

• Study First Submitted: 2010-06-14
• Study First Submitted QC: 2010-06-17
• Study First Posted: 2010-06-22
• Study Start: 2010-08
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Results First Submitted: 2013-11-26
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-21
• Last Update Submitted: 2014-01-21
• Results First Posted: 2014-03-07
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active	N6022	N6022
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers	7 Days	Safety variables - number of adverse events reported during study, changes in vital signs, physical examination findings, telemetry alerts, 12-lead ECG changes, infusion site reactions, O2 saturation changes, and clinical laboratory assessment changes between subjects receiving N6022 versus placebo.

Secondary Outcome Measures

Name	Time	Method
Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration	24 hours	Concentrations of N6022 and metabolite \[N61149)\], collected on Days 1 and 7; predose, end of infusion, and at 10 minutes, 30 minutes, 1, 2, 4, 6, 8, 12, 16, and 24 hours post-dose (the 24 hour postdose collected prior to the start of infusion on Day 2).

Trial Locations

Locations (1)

Parexel Early Phase Unit; 🇺🇸 Baltimore, Maryland, United States