MigrainePhase 1NCT07016516
A Study to Learn About PRT-064040 Nasal Spray in Healthy Adult Subjects
A Phase 1 study testing PRT-064040 nasal spray in people with Migraine, run by Sichuan Purity Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Migraine
- What is being tested?
- PRT-064040 nasal spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 7 Jun 2025to 8 Sep 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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
- Being tested
- PRT-064040 nasal spray, Placebo
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRT-064040 nasal sprayDrug
A single dose of PRT-064040 nasal spray at one of six dose levels
PlaceboDrug
A single dose of Placebo at one of six dose levels
PRT-064040 nasal sprayDrug
Multiple doses of PRT-064040 nasal spray at one of two dose levels, administered once daily (QD) for a total of 7 consecutive days
PlaceboDrug
Multiple doses of Placebo at one of two dose levels, administered once daily (QD) for a total of 7 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| Single dose of PRT-064040 nasal spray | Experimental | Not described Receives: Drug: PRT-064040 nasal spray |
| Single dose of Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
| Multiple doses of PRT-064040 nasal spray | Experimental | Not described Receives: Drug: PRT-064040 nasal spray |
| Multiple doses of Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of adverse events
Measured: From first dose to maximum of 2 days post last dose administration
Secondary outcomes (4)
Pharmacokinetic Parameters: Cmax
Measured: Up to 2 days post last dose administration
Pharmacokinetic Parameters: Tmax
Measured: Up to 2 days post last dose administration
Pharmacokinetic Parameters: AUC
Measured: Up to 2 days post last dose administration
Pharmacokinetic Parameters: Half life
Measured: Up to 2 days post last dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start7 Jun 2025
- Primary completion8 Sep 2025
- Study completion8 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sichuan Purity Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07016516
- Sponsor's protocol ID
- BT-PRT-064-101
- Status last verified
- Dec 2025
- First submitted
- 27 May 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07016516
- Acronym / sponsor ID
- BT-PRT-064-101
- Conditions
- Migraine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Sichuan Purity Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 7 Jun 2025 (actual)
- Primary completion
- 8 Sep 2025 (actual)
- Study completion
- 8 Sep 2025 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRT-064040 nasal sprayA single dose of PRT-064040 nasal spray at one of six dose levels | Drug | Single dose of PRT-064040 nasal spray |
| PlaceboA single dose of Placebo at one of six dose levels | Drug | Single dose of Placebo |
| PRT-064040 nasal sprayMultiple doses of PRT-064040 nasal spray at one of two dose levels, administered once daily (QD) for a total of 7 consecutive days | Drug | Multiple doses of PRT-064040 nasal spray |
| PlaceboMultiple doses of Placebo at one of two dose levels, administered once daily (QD) for a total of 7 consecutive days | Drug | Multiple doses of Placebo |
Primary outcome
The incidence and severity of adverse events
Time frame: From first dose to maximum of 2 days post last dose administration
4 secondary outcomes
Pharmacokinetic Parameters: Cmax
Time frame: Up to 2 days post last dose administration
Pharmacokinetic Parameters: Tmax
Time frame: Up to 2 days post last dose administration
Pharmacokinetic Parameters: AUC
Time frame: Up to 2 days post last dose administration
Pharmacokinetic Parameters: Half life
Time frame: Up to 2 days post last dose administration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PRT-064040 nasal spray in people with Migraine, run by Sichuan Purity Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence and severity of adverse events (time frame: From first dose to maximum of 2 days post last dose administration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.