Clinical Trial of Intranasal Delivery of NT-301 (APPROVE)
A Phase 1, Two-Part Study of Nasal NT-301 Safety, Tolerability, and Pharmacokinetics in Healthy Volunteers: a Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Investigation Followed by an Open-Label, Two-Way, Two-Period, Crossover Evaluation of NT-301 Bioavailability Compared to Subcutaneous Apomorphine
Sponsor: Beyond Drug Development
Listed as NCT06954428, this PHASE1 trial focuses on Performance of NT-301 Nasal Spray Device and Pharmacokinetics of NT-301 Nasal Spray and remains completed. Sponsored by Beyond Drug Development, it has been updated 3 times since 2025, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Status Flow
Change History
3 versions recorded-
Feb 2026 — Present [monthly]
Completed PHASE1
Status: Recruiting → Completed
-
Aug 2025 — Feb 2026 [monthly]
Recruiting PHASE1
Status: Not Yet Recruiting → Recruiting
-
Jun 2025 — Aug 2025 [monthly]
Not Yet Recruiting PHASE1
First recorded
Eligibility Summary
No eligibility information available.
Contact Information
- Beyond Drug Development
- CMAX Clinical Research Pty Limited
- Nano PharmaSolutions Australia
For direct contact, visit the study record on ClinicalTrials.gov .