Title
Safety and Tolerability Study of N6022 in Healthy Subjects
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study Evaluating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic Effect of N6022 in Healthy Subjects
Phase
Phase 1Lead Sponsor
Nivalis Therapeutics, Inc.Study Type
InterventionalStatus
Completed Results PostedIndication/Condition
HealthyIntervention/Treatment
n6022 ...Study Participants
41The purpose of this study is to evaluate the safety and tolerability of N6022 in healthy subjects.
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.
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.
This will be 0.9% normal saline given over 1, 3, or 9 minutes IV bolus.
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
| Event Type | Organ System | Event Term | Cohort 1 | Cohort 2 and 4 | Cohort 3 | Cohort 5 | Cohort 6 | Placebo |
|---|
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.
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).
