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A Study to Learn About PRT-064040 Nasal Spray in Healthy Adult Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT07016516•Sichuan Purity Pharmaceutical Technology Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

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

Exclusion Criteria

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

Locations (1)

The Third Hospital of Changsha

Changsha, Hunan, China

Key Dates

Start Date

June 7, 2025

Primary Completion Date

September 8, 2025

Completion Date

September 8, 2025

Last Updated

December 4, 2025

Enrollment

ACTUAL participants

Conditions

Migraine

Interventions

PRT-064040 nasal spray

DRUG

Placebo

DRUG

PRT-064040 nasal spray

DRUG

Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 4, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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