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.
None
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.
Parallel
Peramivir Inhalation Solution
DrugParticipants 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.
Placebo for Peramivir Inhalation Solution
DrugParticipants 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.
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.
Change From Baseline in Influenza Virus RNA and Viral Titer
Change from baseline in influenza virus RNA measured by quantitative PCR (qPCR; log10 copies/mL) and influenza viral titer (log10 TCID50/mL) at scheduled visits.
Weighted Time to Alleviation of Five Core Influenza Symptoms
Weighted time in hours from initiation of study treatment to alleviation of all five core influenza symptoms: feverishness or chills, cough, nasal congestion, sore throat, and headache. Alleviation is defined as a score of 0 (absent) or 1 (mild) for all five symptoms, maintained for at least 21.5 hours. Symptom-specific weights will be applied as prespecified in the statistical analysis plan.
Time to Influenza Viral RNA Negativity
Time in hours from initiation of study treatment to the first respiratory specimen in which influenza viral RNA is below the assay limit of detection, as measured by quantitative polymerase chain reaction.
Time to Influenza Virus Titer Negativity
Time in hours from initiation of study treatment to the first respiratory specimen in which the infectious influenza virus titer is below the assay lower limit of quantification.
Change From Baseline in Myxovirus Resistance Protein A (MxA) Concentration
Change from baseline in MxA concentration (ng/mL) at protocol-specified post-baseline visits.
Safety and Tolerability
Safety and tolerability will be assessed based on spontaneously reported and directly observed adverse events (AEs), serious adverse events (SAEs), and/or unexpected serious adverse events, as well as clinically significant abnormalities or changes from baseline in vital signs, physical examinations, clinical laboratory tests, and 12-lead electrocardiograms (ECGs). Adverse events will be graded according to the Common Terminology Criteria for Adverse Events (CTCAE), Version 6.0.
Plasma Concentrations and Pharmacokinetic Parameters of Peramivir
Plasma concentrations of peramivir will be measured at prespecified time points following administration. Pharmacokinetic parameters, including maximum observed plasma concentration (Cmax), time to maximum observed plasma concentration (Tmax), area under the plasma concentration-time curve from time zero to the last quantifiable concentration (AUC0-t), area under the plasma concentration-time curve from time zero to infinity (AUC0-∞), terminal elimination half-life (t1/2), elimination rate constant (Ke), apparent volume of distribution (Vd/F), mean residence time (MRT), and apparent total clearance (CL/F), will be estimated using plasma concentration-time data.
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