A Phase II Clinical Study to Evaluate the Efficacy and Safety of YKYY018 for Inhalation Solution

Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-85
SponsorBeijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • YKYY018 for Inhalation Solution

    Drug

    nebulized inhalation, QD or Q2D of the corresponding dose of YKYY018 for inhalation solution

  • YKYY018 Placebo

    Drug

    nebulized inhalation, QD or Q2D of the corresponding dose of YKYY018 placebo

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: YKYY018 groupActive comparator 1 intervention
Group B: YKYY018 Placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The time from initial administration to symptom relief of lower respiratory symptoms on the RiiQ (Respiratory Intensity and Impact Questionnaire) symptom scale

Time frame
within 28 days after administration

Secondary outcomes

1

Adverse events(AEs)

Time frame
within 28 days after administration
2

Serious adverse events (SAEs)

Time frame
within 28 days after administration
3

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)

Time frame
within 28 days after administration

Other outcomes

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: