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NOT YET RECRUITING
NCT07791251
PHASE3

A Multicentre, Randomized, Double-blind, Placebo-controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of Inhaled Peramivir Solution for the Treatment of Adults With Uncomplicated Influenza

Sponsor: Capital Medical University

View on ClinicalTrials.gov

Summary

This multicenter, randomized, double-blind, placebo-controlled, parallel-group Phase 3 study will evaluate the efficacy and safety of peramivir inhalation solution in adults with uncomplicated influenza. Approximately 600 participants aged 18 to 64 years with laboratory-confirmed influenza and symptom onset within 48 hours will be randomized in a 2:1 ratio to receive a single nebulized dose of peramivir inhalation solution 80 mg or matching placebo. The primary efficacy outcome is the time to alleviation of all seven influenza symptoms. Secondary outcomes include changes in influenza viral RNA and infectious viral titers, time to viral clearance, alleviation of respiratory and systemic symptoms, resolution of fever, influenza-related complications, and use of rescue medication. Safety will be assessed through adverse events, clinical laboratory tests, vital signs, physical examinations, and electrocardiograms. Pharmacokinetics will also be evaluated in a subset of approximately 90 participants. Participants will be followed for approximately 15 days.

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

600

Start Date

2026-10-28

Completion Date

2028-05-06

Last Updated

2026-08-27

Healthy Volunteers

No

Interventions

DRUG

Peramivir Inhalation Solution

Participants will receive a single nebulized dose of matching placebo on Day 1. The placebo will be administered as two 2-mL ampules containing no active peramivir. Nebulization will last at least 15 minutes. Participants will remain under observation at the study site for 30 minutes after completion of administration.

DRUG

Placebo for Peramivir Inhalation Solution

Participants will receive a single nebulized administration of matching placebo on Day 1. Two 2-mL placebo ampules containing no active peramivir will be placed in the nebulizer, for a total volume of 4 mL. Nebulization will last at least 15 minutes. Participants will remain under observation at the study site for 30 minutes after completion of administration.

Locations (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China