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

September 6, 2026 updated by: Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.

A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Study to Evaluate the Efficacy and Safety of YKYY018 for Inhalation Solution in Adult Participants With Respiratory Syncytial Virus Infection

A phase II clinical study to evaluate the efficacy and safety of YKYY018 for inhalation solution in adult participants with respiratory syncytial virus infection

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This is a randomized, double-blind,placebo-controlled phase II clinical study to investigate the efficacy and safety of YKYY018 for inhalation solution in adult participants with respiratory syncytial virus infection

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China
        • China-Japan Friendship Hospital
        • Contact:
          • Phone Number: +86-010-84206264

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Participant must voluntarily consent to participate in this study and provide their written informed consent prior to start of any study-specific procedures.
  2. Participant must be between 18 and 85 years of age (inclusive), no gender restrictions.
  3. Diagnosed with RSV infection through antigen or nucleic acid testing within 24 hours prior to screening.
  4. 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.
  5. Female participants with fertility tested negative for blood pregnancy during the screening period. Male and female trial participants, as well as their reproductive age female partners, must start using effective contraception measures at least half a month before screening (3 months for oral contraceptives), agree to use effective contraception measures (abstinence, previous sterilization, hormone and/or barrier methods) during the study period and within one month after the end of the trial, and are not allowed to donate ovum/sperm during the period.
  6. Participants are able to communicate effectively with the researcher and understand and comply with the requirements of this study.

Exclusion Criteria:

  1. 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.
  2. Diagnosis of influenza or novel coronavirus infection within 7 days before screening.
  3. Suspected of merging with other respiratory pathogens that require anti infective drug treatment.
  4. Based on imaging and the researcher's judgment, patients with active tuberculosis, untreated tuberculosis or incomplete tuberculosis history.
  5. Planned to undergo bone marrow, stem cell, or other organ transplantation during the research period, or currently receiving immunomodulatory therapy (such as systemic glucocorticoids or immunosuppressants).
  6. Accompanied by severe or unstable central nervous system, cardiovascular, respiratory system (such as requiring long-term oxygen therapy), liver, kidney, gastrointestinal, urinary system, endocrine system, or hematological system diseases, which researchers believe may confuse the research results or affect the safety of participants.
  7. Individuals with a history of malignant tumors within the past 5 years (excluding non metastatic skin basal cell or squamous cell carcinoma that is currently stable and has received appropriate treatment or resection, as well as cervical cancer in situ), or those currently under evaluation for potential malignant tumors.
  8. Unable to communicate or cooperate with medical staff due to neurological, psychiatric, or language disorders.
  9. Any history of mechanical ventilation treatment within 30 days prior to screening (excluding general anesthesia for surgery).
  10. Participants who cannot tolerate nebulized inhalation or have severe oral and/or maxillofacial deformities that affect the use of nebulized inhalers.
  11. During the screening period, individuals with alanine aminotransferase (ALT), aspartate aminotransferase (AST) levels greater than 2 times the upper limit of normal (ULN), total bilirubin levels greater than 1.5 times ULN, or serum creatinine levels greater than 1.5 times ULN, or other laboratory test results that are clinically significant and may affect the evaluation of this trial, as determined by the researchers.
  12. Participants have used within 3 days or 5 half lives (whichever is longer) before the first administration, or plan to use any research prohibited drugs during the study (prohibited drugs include interferon, ribavirin and drugs with antiviral effect/traditional Chinese patent medicines and simple preparations clearly listed in the drug manual).
  13. Received RSV vaccine within 6 months prior to screening, or received any other vaccine (excluding inactivated vaccines) within 4 weeks prior to initial administration, or planned to receive the vaccine during the study.
  14. Individuals who have participated in any other clinical trials and used investigational drugs or medical devices within one month or five half lives prior to screening (whichever is longer).
  15. Known history of allergies or any severe allergic diseases to the investigational drug or its components.
  16. Individuals who have undergone major surgeries within the previous month prior to screening; Or those who have not recovered after surgery during the screening period.
  17. Participants who are known to be positive for human immunodeficiency virus (HIV-1 or HIV-2) antibodies.
  18. History of drug abuse within the past 12 months prior to screening.
  19. Despite guidance from the researcher, the participan is still unable to cooperate in completing the Respiratory Intensity and Impact Questionnaire (RiiQ)
  20. Participants may not be able to complete the study for other reasons, or may be deemed unsuitable for inclusion by the researcher.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: YKYY018 group
Drug: YKYY018 for Inhalation Solution
nebulized inhalation, QD or Q2D of the corresponding dose of YKYY018 for inhalation solution
Placebo Comparator: YKYY018 Placebo group
Drug: YKYY018 Placebo
nebulized inhalation, QD or Q2D of the corresponding dose of YKYY018 placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
within 28 days after administration

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Adverse events(AEs)
Time Frame: within 28 days after administration
within 28 days after administration
Serious adverse events (SAEs)
Time Frame: within 28 days after administration
within 28 days after administration
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
within 28 days after administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 10, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 10, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 10, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLSP-YKYY018-Z03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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