NCT07016516

A Study to Learn About PRT-064040 Nasal Spray in Healthy Adult Subjects

A Phase I, Randomized, Double-blind, Placebo-controlled, Single and Multiple Doses Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of PRT-064040 Nasal Spray in Healthy Adult Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This trial is a Phase I, single-center, randomized, double-blind, placebo-controlled study conducted in healthy Chinese adult subjects. The purpose of this study is to learn about: * Safety and tolerability of PRT-064040 nasal spray in healthy adult subjects. * Pharmacokinetics after single and multiple dose of PRT-064040 nasal spray in healthy Chinese adult subjects. This study is divided into two parts: * Eligible subjects in Part A will receive a single dose of PRT-064040 nasal spray or placebo. * Eligible subjects in Part B will receive multiple doses of PRT-064040 nasal spray or placebo, administered once daily (QD) for a total of 7 consecutive days.

Conditions

• Migraine

Interventions

Type	Name	Description
DRUG	PRT-064040 nasal spray	A single dose of PRT-064040 nasal spray at one of six dose levels
DRUG	Placebo	A single dose of Placebo at one of six dose levels
DRUG	PRT-064040 nasal spray	Multiple doses of PRT-064040 nasal spray at one of two dose levels, administered once daily (QD) for a total of 7 consecutive days
DRUG	Placebo	Multiple doses of Placebo at one of two dose levels, administered once daily (QD) for a total of 7 consecutive days

Timeline

• Start date: 2025-06-07
• Primary completion: 2025-09-08
• Completion: 2025-09-08
• First posted: 2025-06-11
• Last updated: 2025-12-04

Locations

1 site across 1 country: China