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

NCT07791251 | Not Yet Recruiting Phase 3

• 1 other identifier: YW2026-060-01
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza Infection

Outcome Measures

Primary Outcomes (1)

• Time to Alleviation of All Influenza Symptoms

  Time in hours from initiation of study treatment to alleviation of all seven influenza symptoms recorded in the participant diary. The seven symptoms are nasal congestion, sore throat, cough, muscle or joint pain, fatigue, headache, and feverishness or chills. Alleviation is defined as a score of 0 (absent) or 1 (mild) for all seven symptoms, maintained for at least 21.5 hours.

  From initiation of study treatment through 336 hours after treatment

Secondary Outcomes (15)

• Change From Baseline in Influenza Virus RNA and Viral Titer

  Baseline (pre-dose), Days 2, 3, 4, 5, Day 9 ± 2 days, and Day 15 (+3 days)/early withdrawal.

• Weighted Time to Alleviation of Five Core Influenza Symptoms

  From initiation of study treatment through 336 hours after treatment

• Time to Influenza Viral RNA Negativity

  From initiation of study treatment through Day 15 (+3 days)

• Time to Influenza Virus Titer Negativity

  From initiation of study treatment through Day 15 (+3 days)

• Proportion of Participants With Influenza Virus RNA Below the LOD and Viral Titer Below the LLOQ

  Baseline, Days 2, 3, 4, 5, Day 9 ± 2 days, and Day 15 (+3 days)/early withdrawal.

Other Outcomes (3)

• Change From Baseline in Myxovirus Resistance Protein A (MxA) Concentration

  Baseline and protocol-specified visits through Day 15 (+3 days)/early withdrawal.

• Safety and Tolerability

  From the first administration of study treatment through Day 15 (+3 days)/early withdrawal.

• Plasma Concentrations and Pharmacokinetic Parameters of Peramivir

  From Day 1 post-dose through Day 5.

Study Arms (2)

Peramivir Inhalation Solution

EXPERIMENTAL

Participants will receive a single nebulized dose of peramivir inhalation solution 80 mg on Day 1. The 80-mg dose will be administered as two 2-mL ampules, each containing 40 mg of 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: Peramivir Inhalation Solution

Placebo for Peramivir Inhalation Solution

PLACEBO COMPARATOR

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

Interventions

Peramivir Inhalation Solution DRUG

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.

Peramivir Inhalation Solution

Placebo for Peramivir Inhalation Solution DRUG

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.

Placebo for Peramivir Inhalation Solution

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Participants must meet all of the following criteria:
• The participant or the participant's legally authorized representative understands the study and voluntarily signs the informed consent form. The participant must be 18 to 64 years of age, inclusive, at the time of informed consent.
• At screening, the participant meets all of the following criteria:
• Positive result from a rapid influenza diagnostic test (antigen test) or polymerase chain reaction (PCR) test.
• Axillary temperature of at least 37.3°C at screening. If an antipyretic has been taken, the axillary temperature must be at least 37.3°C at least 4 hours after administration.
• At least one influenza-related systemic symptom of moderate or greater severity: muscle or joint pain, fatigue, headache, or feverishness/chills.
• At least one influenza-related respiratory symptom of moderate or greater severity: nasal congestion, sore throat, or cough.
• The interval between the onset of the first influenza symptom and initiation of study treatment is no more than 48 hours. Symptom onset is defined as either:
• The first occurrence of a temperature of at least 37.3°C measured axillary, 37.5°C measured orally, or 38.0°C measured rectally or tympanically; or The onset of at least one systemic or respiratory symptom: nasal congestion, sore throat, cough, muscle or joint pain, fatigue, headache, or feverishness/chills.
• The participant is able to comply with all study procedures and complete the participant diary as required.
• A female participant must meet either of the following criteria:
• Not of childbearing potential, defined as having undergone hysterectomy or bilateral oophorectomy, having medically documented ovarian failure, or being postmenopausal. Postmenopausal status is defined as age greater than 50 years with amenorrhea for at least 12 months; or Of childbearing potential, with a negative pregnancy test at screening, and not pregnant, in the peripartum period, or breastfeeding.
• The participant and the participant's partner agree to remain completely abstinent or use effective contraception from screening through 3 months after completion of study treatment. Acceptable methods include:
• For a female participant or the female partner of a male participant, one of the following methods together with correct condom use by the male partner: an intrauterine device with an annual failure rate of less than 1%, a female barrier method consisting of a cervical cap or diaphragm with spermicide, or tubal sterilization; or Prior vasectomy of the male participant or the male partner of a female participant.
• Male participants agree not to donate sperm from screening through 3 months after completion of study treatment.

You may not qualify if:

• Participants meeting any of the following criteria will be excluded:
• Influenza requiring hospitalization, as indicated by any of the following:
• Severe influenza characterized by one or more of the following:
• Persistent fever accompanied by severe cough, purulent sputum, bloody sputum, or chest pain.
• Tachypnea, difficulty breathing, or cyanosis of the lips.
• Altered mental status, including reduced responsiveness, somnolence, or agitation, or the occurrence of seizures.
• Severe vomiting or diarrhea with evidence of dehydration.
• Pneumonia.
• Marked exacerbation of a pre-existing underlying disease.
• Any other clinical condition requiring hospitalization.
• Critical influenza characterized by one or more of the following:
• Respiratory failure.
• Acute necrotizing encephalopathy.
• Shock.
• Multiple organ dysfunction.

Sponsors & Collaborators

• Capital Medical University: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100, China

Location

Central Study Contacts

Yeming Wang, PhD

CONTACT

+86 18810663558; wwyymm_love@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President, Chinese Thoracic Society (CTS) Director, Department of Pulmonary and Critical Care Medicine, China-Japan Friendship Hospital Professor of Pulmonary and Critical Care Medicine, Capital Medical University

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): October 28, 2026
• Primary Completion (Estimated): April 6, 2028
• Study Completion (Estimated): May 6, 2028
• Last Updated: August 27, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)