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NCT Number: NCT07016516

A Study to Learn About PRT-064040 Nasal Spray in Healthy Adult Subjects

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The Third Hospital of Changsha

Changsha, Hunan, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • History of significant alcohol abuse or drug abuse.
  • 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.

Treatment and study plan

PRT-064040 nasal spray

Drug

A single dose of PRT-064040 nasal spray at one of six dose levels

Placebo

Drug

A single dose of Placebo at one of six dose levels

Primary outcomes

  1. The incidence and severity of adverse events

    Time frame: From first dose to maximum of 2 days post last dose administration

Secondary outcomes

  1. Pharmacokinetic Parameters: Cmax

    Time frame: Up to 2 days post last dose administration

  2. Pharmacokinetic Parameters: Tmax

    Time frame: Up to 2 days post last dose administration

  3. Pharmacokinetic Parameters: AUC

    Time frame: Up to 2 days post last dose administration

  4. Pharmacokinetic Parameters: Half life

    Time frame: Up to 2 days post last dose administration

Sponsors and collaborators

Lead sponsor

Sichuan Purity Pharmaceutical Technology Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2025
Registry last updated
Dec 4, 2025

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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