Safety and Tolerability Study of N6022 in Healthy Subjects

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


The 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.

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


Healthy Subjects


N6022, Placebo


Parexel Early Phase Unit
United States


Not yet recruiting


N30 Pharmaceuticals LLC

Results (where available)

View Results


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

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