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

NCT07016516 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-12-04

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PRT-064040 nasal spray

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

DRUG

Placebo

A single dose of Placebo at one of six dose levels

DRUG

PRT-064040 nasal spray

Multiple doses of PRT-064040 nasal spray at one of two dose levels, administered once daily (QD) for a total of 7 consecutive days

DRUG

Placebo

Multiple doses of Placebo at one of two dose levels, administered once daily (QD) for a total of 7 consecutive days

Sponsors & Collaborators

  • Sichuan Purity Pharmaceutical Technology Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-06-07
Primary Completion
2025-09-08
Completion
2025-09-08

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07016516 on ClinicalTrials.gov