NCT04379869

To Evaluate the Safety, Tolerability and Pharmacokinetics of Oral NNZ-2591 in Healthy Volunteers

A Combined Single Dose and Multiple Ascending Dose Study to Assess the Safety, Tolerability and Pharmacokinetic Profile of NNZ-2591 in Healthy Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Neuren Pharmaceuticals Limited · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the safety, tolerability and pharmacokinetics of NNZ-2591 when administered to healthy volunteers.

Detailed description

This study is in two stages: Stage 1: A First-in-Human (FIH), single dose escalation study of oral NNZ-2591 in healthy volunteers to establish safety, tolerability and pharmacokinetic parameters. Stage 2: A First-in-Human (FIH), randomised, double-blind, placebo-controlled, Multiple Ascending Dose study (MAD) in healthy volunteers to establish safety, tolerability and pharmacokinetic parameters.

Conditions

• Healthy Volunteers

Interventions

Type	Name	Description
DRUG	NNZ-2591	Single dose of NNZ-2591
DRUG	Placebo	Comparator for double-blind MAD

Timeline

• Start date: 2020-05-29
• Primary completion: 2021-02-11
• Completion: 2021-02-11
• First posted: 2020-05-08
• Last updated: 2021-07-09

Locations

2 sites across 1 country: Australia