Safety and Tolerability Study of N6022 in Healthy Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2011-06-30

Brief Summary

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

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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.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Active

N6022

Group Type EXPERIMENTAL

N6022

Intervention Type DRUG

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.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

This will be 0.9% normal saline given over 1, 3, or 9 minutes IV bolus.

Interventions

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N6022

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.

Intervention Type DRUG

Placebo

This will be 0.9% normal saline given over 1, 3, or 9 minutes IV bolus.

Intervention Type DRUG

Other Intervention Names

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N6022

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes