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

NCT07016516 | Completed Phase 1

• 1 other identifier: BT-PRT-064-101
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of adverse events

  From first dose to maximum of 2 days post last dose administration

Secondary Outcomes (4)

• Pharmacokinetic Parameters: Cmax

  Up to 2 days post last dose administration

• Pharmacokinetic Parameters: Tmax

  Up to 2 days post last dose administration

• Pharmacokinetic Parameters: AUC

  Up to 2 days post last dose administration

• Pharmacokinetic Parameters: Half life

  Up to 2 days post last dose administration

Study Arms (4)

Single dose of PRT-064040 nasal spray

EXPERIMENTAL

Drug: PRT-064040 nasal spray

Single dose of Placebo

PLACEBO COMPARATOR

Drug: Placebo

Multiple doses of PRT-064040 nasal spray

EXPERIMENTAL

Drug: PRT-064040 nasal spray

Multiple doses of Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

PRT-064040 nasal spray DRUG

A single dose of PRT-064040 nasal spray at one of six dose levels

Single dose of PRT-064040 nasal spray

Placebo DRUG

A single dose of Placebo at one of six dose levels

Single dose of Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female Chinese adults aged ≥18 years and ≤55 years.
• Body Mass Index of 18 to 28 kg/m\^2; and a total body weight ≥50 kg for males and ≥45 kg for females.

You may not qualify if:

• History of allergy to any medications, foods, or other substances.
• History or presence of any severe diseases that are considered clinically significant by the investigator.
• Any clinically significant abnormal laboratory test results or positive test.
• Any nasal conditions or diseases that, in the investigator's judgment, may significantly affect the administration or absorption of a nasal product.
• Standard 12-Lead Electrocardiogram that demonstrates clinically relevant abnormalities.
• Pregnant or breastfeeding women, or those with a positive pregnancy test result during screening.
• Positive urine drug screen, alcohol breath test, or nicotine test.
• History of significant alcohol abuse or drug abuse.
• Donation or loss of blood of approximately 400 mL or more within 3 months prior to dosing.
• Previous participation in another clinical trial and receiving the investigational drug within 3 months prior to dosing.

Sponsors & Collaborators

• Sichuan Purity Pharmaceutical Technology Co., Ltd.: lead

Study Sites (1)

The Third Hospital of Changsha

Changsha, Hunan, China

Location

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2025
• First Posted: June 11, 2025
• Study Start: June 7, 2025
• Primary Completion: September 8, 2025
• Study Completion: September 8, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)