The Third Hospital of Changsha
Changsha, Hunan, China
NCT Number: NCT07016516
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.
Looking for future studies?
Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Changsha, Hunan, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A single dose of PRT-064040 nasal spray at one of six dose levels
A single dose of Placebo at one of six dose levels
Time frame: From first dose to maximum of 2 days post last dose administration
Time frame: Up to 2 days post last dose administration
Time frame: Up to 2 days post last dose administration
Time frame: Up to 2 days post last dose administration
Time frame: Up to 2 days post last dose administration
Sichuan Purity Pharmaceutical Technology Co., Ltd.
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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