NCT07016516CompletedPhase 1
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
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 80 (actual)
- First submitted
- 27 May 2025
- Start date
- 7 Jun 2025
- Primary completion date
- 8 Sept 2025
- Lead sponsor
- Sichuan Purity Pharmaceutical Technology Co., Ltd.
- Diseases
- Migraine
- NCT number
- NCT07016516
What you commit to
- Study type: Interventional · Phase 1
- Participants enrolled: 80
- From 7 Jun 2025 to the primary completion date, 8 Sept 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Positive urine drug screen, alcohol breath test, or nicotine test.
- 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.
Other illness
- 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 nasal conditions or diseases that, in the investigator's judgment, may significantly affect the administration or absorption of a nasal product.
- History of significant alcohol abuse or drug abuse.
Lab values
- Any clinically significant abnormal laboratory test results or positive test.
Other
- Standard 12-Lead Electrocardiogram that demonstrates clinically relevant abnormalities.
- Pregnant or breastfeeding women, or those with a positive pregnancy test result during screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to 55 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Third Hospital of Changsha Coordinator of this site? Confirm its status | Changsha | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.