Safety and Tolerability Study of N6022 in Healthy Subjects

Nivalis Therapeutics

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: N6022

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01147406

N6022-1H1-01

Details and patient eligibility

About

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

Full 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.

Enrollment

41 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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