About this trial
A phase II clinical study to evaluate the efficacy and safety of YKYY018 for inhalation solution in adult participants with respiratory syncytial virus infection
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Participant must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures.
Participant must be between 18 and 85 years of age (inclusive), no gender restrictions.
Diagnosed with RSV infection through antigen or nucleic acid testing within 24 hours prior to screening.
Participants must have at least one new onset of lower respiratory tract infection symptoms or worsening of existing lower respiratory tract symptoms (including cough), and the severity of any individual symptom is moderate or severe (RiiQ score ≥ 2), with an expected interval of no more than 72 hours between the onset of RSV infection symptoms and the first dose.
Disqualifiers
At the time of screening, the patient had already been hospitalized for treatment, or it was determined by the researcher that hospitalization is expected within 24 hours after screening.
Diagnosis of influenza or novel coronavirus infection within 7 days before screening.
Suspected of merging with other respiratory pathogens that require anti infective drug treatment.
Based on imaging and the researcher's judgment, patients with active tuberculosis, untreated tuberculosis or incomplete tuberculosis history.
Trial design
Parallel
Treatments tested in this trial
YKYY018 for Inhalation Solution
Drugnebulized inhalation, QD or Q2D of the corresponding dose of YKYY018 for inhalation solution
YKYY018 Placebo
Drugnebulized inhalation, QD or Q2D of the corresponding dose of YKYY018 placebo
Treatment groups
Trial outcomes
Primary outcomes
The time from initial administration to symptom relief of lower respiratory symptoms on the RiiQ (Respiratory Intensity and Impact Questionnaire) symptom scale
Secondary outcomes
Adverse events(AEs)
Serious adverse events (SAEs)
The time between the start of the q wave and the end of the t wave on an electrocardiogram/Corrected QT interval(QT/QTc) in 12-lead electrocardiogram (ECG)
Sponsors and contacts
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This trial is not recruiting at the moment. You can still explore other options: