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Safety and Tolerability Study of N6022 in Healthy Subjects

2014-08-27 03:12:48 | BioPortfolio

Summary

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

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 Design

Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Healthy Subjects

Intervention

N6022, Placebo

Location

Parexel Early Phase Unit
Baltimore
Maryland
United States
21225

Status

Not yet recruiting

Source

N30 Pharmaceuticals LLC

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:12:48-0400

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