drugset / Trial / NCT06954428
Clinical Trial of Intranasal Delivery of NT-301
Phase 1
Completed
49 enrolled
Nano PharmaSolutions Australia
Beyond Drug Development · collabCMAX Clinical Research Pty Ltd · collab
RandomizedSequentialTriple-blindTreatment
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.
Timeline
- Start
- 2025-06-20
- Primary completion
- 2025-12-12
- Completion
- 2025-12-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Apomorphine | Unknown | 1 mg | Intranasal |
| Subject | Apomorphine | Unknown | 2 mg | Intranasal |
| Subject | Apomorphine | Unknown | 3 mg | Intranasal |
| Subject | Apomorphine | Unknown | 4 mg | Intranasal |
Indications
No indication recorded.