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
Abstract
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.
Primary outcome: The incidence and severity of adverse events.
Enrollment: 80 participants.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 80 participants or records.
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