Clinical Trial

Clinical Trial of Intranasal Delivery of NT-301

Study acronym: APPROVE
Completed Phase 1
View on ClinicalTrials.gov →
Summary
The purpose of this research project is to investigate the safety and tolerability of an approved drug (Apomorphine) when administered as a nasal powder spray formulation (NT-301) as well as collect information on how NT-301 moves into, through and out of your body, called Pharmacokinetics. The study also aims to compare the safety, tolerability and pharmacokinetics of NT-301 to an injectable Apomorphine product (Movapo Pen), already approved for use in Australia.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-04-24; most recent amendment 2026-02-17.
Status change: Recruiting → Completed 2026-02-17
Status change: Not Yet Recruiting → Recruiting 2025-07-08
Trial Details
NCT Number NCT06954428
Lead Sponsor Nano PharmaSolutions Australia
Collaborators: CMAX Clinical Research Pty Limited, Beyond Drug Development
Conditions Tolerability of NT-301 Nasal Spray, Pharmacokinetics of NT-301 Nasal Spray, Safety of NT-301 Nasal Spray, Performance of NT-301 Nasal Spray Device
Enrollment 49 participants
Start Date 2025-06-20
Primary Completion 2025-12-12 (estimated)
Study Completion 2025-12-12 (estimated)
Updated on ClinicalTrials.gov 2026-02-19