Safety and Tolerability Study of N6022 in Healthy Subjects

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

Detailed Description
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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.

Official Title
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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

Conditions
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Healthy

Intervention / Treatment
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* Drug: N6022
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>N6022 | Drug: N6022<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* This will be 0.9% normal saline given over 1, 3, or 9 minutes IV bolus.<br>* Other names: N6022;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of a Single Ascending Doses of Intravenous N6022 in Healthy Volunteers | 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. | 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum N6022 and Metabolite Concentrations in Plasma Within 24 Hours of End of Administration | 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). | 24 hours |