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New migraine nasal spray enters first human safety trial

NCT ID NCT07016516

Symptom relief Sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This early-stage study tested a new nasal spray called PRT-064040 in 80 healthy Chinese adults to see if it is safe and how the body processes it. Participants received either a single dose or seven daily doses of the spray or a placebo. The study does not yet test if the spray helps migraines, but it is a first step toward a potential new treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PRT-064040 nasal spray
What this could lead to
If this early study shows the drug is safe, it could lead to a new nasal spray option for treating migraine attacks.
What could go wrong
This is a very early Phase 1 trial in healthy people, not migraine patients. It only tests safety and how the drug moves through the body, not whether it actually works for migraines.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

80 people

The number who actually took part.

Started

Jun 2025

Finished

Sep 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

migraine disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Migraine

Contacts and locations

Locations

  • The Third Hospital of Changsha

    Changsha, Hunan, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.