A Phase 3 interventional study of Peramivir Inhalation Solution and Placebo for Peramivir Inhalation Solution in Influenza Infection, sponsored by Capital Medical University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by Capital Medical University · Phase 3, Interventional, and Treatment
Among 12 studies in Influenza, Human by Capital Medical University — 7 open to participants now, 7 under way, 3 of them phase 3. Influenza, Human · Capital Medical University.
Among the 12 studies in Influenza, Human by Capital Medical University, this one is the 2nd largest by planned enrollment of the 11 interventional ones that give a count, is one of 3 that started in 2026, is one of 3 in phase 3, and was the 10th registered.
2,358 studies on the registry are indexed under Influenza, Human; 185 are open to participants now.
Browse Influenza, Human studies →7 of the 12 studies in Influenza, Human by Capital Medical University are open now, in 1 country. Recruiting first, the newest first:
Capital Medical University · Sites in China
Ages 12+
Capital Medical University · Sites in China
Ages 18–65
Capital Medical University · Sites in China
Ages 18+
Capital Medical University · Sites in China
Ages 12–65
Capital Medical University · Sites in China
Ages 2+ · Healthy volunteers
By country, each count listing its studies:
Of the 120 Influenza, Human studies recruiting now, 64 (53%) set no upper age limit and 46 (38%) stop at 75 or younger; 33 take children under 18; 66 take healthy volunteers.
This study: 18 Years to 64 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
12 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 2 · Phase 3 4 · Phase 4 2
First in 2009; this study’s year is marked. 3 started in 2026.
This study's planned enrollment of 600 is above the median of 227 across 1,957 interventional studies indexed under Influenza, Human.
Median enrollment 384 across the 11 interventional studies, 1,000 across the 1 observational. Of the 4 that completed or were terminated, 0 (0%) have results posted.
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Capital Medical University is the lead sponsor of 296 studies on the registry; 90 are open to participants now.
2 of the studies in Influenza, Human by Capital Medical University that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07236814Phase 3Capital Medical UniversitySuraxavir Marboxil And Oseltamivir for Influenza Prophylaxis Under a Hospital-based Setting | 2027-03-01 |
| NCT07893847Phase 3Capital Medical UniversityEvaluation of the Efficacy and Safety of 102D-6 in the Treatment of Acute Uncomplicated Influenza | 2027-03-30 |
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Among the 12 studies in Influenza, Human by Capital Medical University, from their registry updates:
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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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
The participant or the participant's legally authorized representative understands the study and voluntarily signs the 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 , defined as having undergone hysterectomy or bilateral oophorectomy, having medically documented ovarian failure, or being . 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 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.
Exclusion Criteria:
Participants meeting any of the following criteria will be excluded:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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 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.
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.
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.
Time frame: From initiation of study treatment through 336 hours after treatment
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.
Time frame: 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
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 frame: From initiation of study treatment through 336 hours after treatment
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 frame: From initiation of study treatment through Day 15 (+3 days)
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.
Time frame: 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
Proportion of participants with influenza virus RNA below the qPCR LOD and influenza viral titer below the LLOQ at each scheduled visit.
Time frame: Baseline, Days 2, 3, 4, 5, Day 9 ± 2 days, and Day 15 (+3 days)/early withdrawal.
Percentage of Participants With Alleviation of All Influenza Symptoms
Percentage of participants with scores of 0 (absent) or 1 (mild) for all seven influenza symptoms, maintained for at least 21.5 hours.
Time frame: Assessed repeatedly from initiation of study treatment through 336 hours after treatment
Percentage of Participants With Alleviation of All Respiratory Symptoms
Percentage of participants with scores of 0 (absent) or 1 (mild) for all three respiratory symptoms-nasal congestion, sore throat, and cough-maintained for at least 21.5 hours.
Time frame: Assessed repeatedly from initiation of study treatment through 336 hours after treatment
Time to Alleviation of All Respiratory Symptoms
Time in hours from initiation of study treatment to alleviation of nasal congestion, sore throat, and cough. Alleviation is defined as a score of 0 (absent) or 1 (mild) for all three symptoms, maintained for at least 21.5 hours.
Time frame: From initiation of study treatment through 336 hours after treatment
Percentage of Participants With Alleviation of All Systemic Symptoms
Percentage of participants with scores of 0 (absent) or 1 (mild) for all four systemic symptoms-muscle or joint pain, fatigue, headache, and feverishness or chills-maintained for at least 21.5 hours.
Time frame: Assessed repeatedly from initiation of study treatment through 336 hours after treatment
Time to Alleviation of All Systemic Symptoms
Time in hours from initiation of study treatment to alleviation of muscle or joint pain, fatigue, headache, and feverishness or chills. Alleviation is defined as a score of 0 (absent) or 1 (mild) for all four symptoms, maintained for at least 21.5 hours.
Time frame: From initiation of study treatment through 336 hours after treatment
Time to Alleviation of Each Individual Influenza Symptom
Time in hours from initiation of study treatment to alleviation of each of the seven influenza symptoms, assessed separately: 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), maintained for at least 21.5 hours.
Time frame: From initiation of study treatment through 336 hours after treatment
Time to Alleviation of Fever
Time in hours from initiation of study treatment to the first axillary temperature below 37.0°C that is maintained for at least 12 hours.
Time frame: From initiation of study treatment through 336 hours after treatment
Percentage of Participants With Normalization of Body Temperature
Percentage of participants with an axillary temperature below 37.0°C that is maintained for at least 12 hours.
Time frame: At 24, 48, 72, 96, 120, 144, and 168 hours after initiation of study treatment
Percentage of Participants With Influenza-Related Complications
Percentage of participants experiencing one or more influenza-related complications, including hospitalization, death, sinusitis, bronchitis, otitis media, or radiographically confirmed pneumonia.
Time frame: From initiation of study treatment through Day 15 (+3 days)
Use of Acetaminophen for Influenza-Related Symptoms
Proportion of participants using acetaminophen and frequency of acetaminophen use during the study treatment period.
Time frame: From initiation of study treatment through 336h.
Change From Baseline in Myxovirus Resistance Protein A (MxA) Concentration
Change from baseline in MxA concentration (ng/mL) at protocol-specified post-baseline visits.
Time frame: Baseline and protocol-specified visits through Day 15 (+3 days)/early withdrawal.
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.
Time frame: From the first administration of study treatment through Day 15 (+3 days)/early withdrawal.
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.
Time frame: From Day 1 post-dose through Day 5.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for Apr 2028, 17 months later.
Of 35 non-industry phase 3 interventional studies under Influenza, Human, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 41. This study's planned 17 months is close to that.
Counting every sponsor, half of 153 studies reached it within 8 months; a quarter within 4 and three quarters within 15.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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