Clinical Trial of Intranasal Delivery of NT-301
NCT06954428 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 49
Last updated 2026-02-19
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.
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
Interventions
- COMBINATION_PRODUCT
-
NT-301 1 mg
unidose of 1 mg apomorphine through nasal spray
- COMBINATION_PRODUCT
-
NT-301 2 mg
unidose of 2 mg apomorphine through nasal spray
- COMBINATION_PRODUCT
-
Placebo 1 mg
Matching Placebo to NT-301 1 mg
- COMBINATION_PRODUCT
-
Placebo 2 mg
Matching Placebo to NT-301 2 mg
- COMBINATION_PRODUCT
-
Placebo 3 mg
Matching Placebo to NT-301 3 mg
- COMBINATION_PRODUCT
-
NT-301 3 mg
unidose apomorphine nasal spray 3 mg
- COMBINATION_PRODUCT
-
NT-301 4 mg
unidose apomorphine nasal spray 4 mg
- COMBINATION_PRODUCT
-
Placebo 4 mg
Matching placebo to NT-301 4 mg
- DRUG
-
Active Comparator: Movapo pen
Approved drug in Australia
- DRUG
-
Experimental: BA NT-301 strength 4 mg
Combination Product: NT-301 apomorphine nasal spray strength 4 mg given by 2 mg on each nostril (2x2 mg)
Sponsors & Collaborators
-
CMAX Clinical Research Pty Limited
collaborator UNKNOWN -
Beyond Drug Development
collaborator UNKNOWN -
Nano PharmaSolutions Australia
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2025-06-20
- Primary Completion
- 2025-12-12
- Completion
- 2025-12-12
- FDA Drug
- Yes
- FDA Device
- Yes
Countries
- Australia
Study Locations
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