Clinical trial NCT07016516: A Study to Learn About PRT-064040 Nasal Spray in Healthy Adult Subjects
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Migraine
Lead sponsor: Sichuan Purity Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2025-06-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: The incidence and severity of adverse events
timeFrame: From first dose to maximum of 2 days post last dose administration
Secondary outcomes:
measure: Pharmacokinetic Parameters: Cmax
timeFrame: Up to 2 days post last dose administration
measure: Pharmacokinetic Parameters: Tmax
timeFrame: Up to 2 days post last dose administration
measure: Pharmacokinetic Parameters: AUC
timeFrame: Up to 2 days post last dose administration
measure: Pharmacokinetic Parameters: Half life
timeFrame: Up to 2 days post last dose administration
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Third Hospital of Changsha
state: Hunan
Study officials:
References: