A Study to Learn About PRT-064040 Nasal Spray in Healthy Adult Subjects (NCT07016516) | Clinical Trial Compass
CompletedPhase 1
A Study to Learn About PRT-064040 Nasal Spray in Healthy Adult Subjects
China80 participantsStarted 2025-06-07
Plain-language 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.
Who can participate
Age range18 Years – 55 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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.
Exclusion criteria
✕. 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.
✕. Positive urine drug screen, alcohol breath test, or nicotine test.
What they're measuring
1
The incidence and severity of adverse events
Timeframe: From first dose to maximum of 2 days post last dose administration