Respiratory Syncytial Virus (RSV)Phase 2NCT07808268
A Phase II Clinical Study to Evaluate the Efficacy and Safety of YKYY018 for Inhalation Solution
A Phase 2 study testing YKYY018 for Inhalation Solution in people with Respiratory Syncytial Virus (RSV), run by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. at 1 site in China.
Trial summary
A phase II clinical study to evaluate the efficacy and safety of YKYY018 for inhalation solution in adult participants with respiratory syncytial virus infection Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Respiratory Syncytial Virus (RSV)
- What is being tested?
- YKYY018 for Inhalation Solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 10 Oct 2026to 10 Mar 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
- Participants are able to communicate effectively with the researcher and understand and comply with the requirements of this study.
Who cannot join
- 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.
- 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).
- 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.
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- 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.
- Unable to communicate or cooperate with medical staff due to neurological, psychiatric, or language disorders.
- Any history of mechanical ventilation treatment within 30 days prior to screening (excluding general anesthesia for surgery).
- Participants who cannot tolerate nebulized inhalation or have severe oral and/or maxillofacial deformities that affect the use of nebulized inhalers.
- 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.
- 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).
- 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.
- 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).
- Known history of allergies or any severe allergic diseases to the investigational drug or its components.
- 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.
- Participants who are known to be positive for human immunodeficiency virus (HIV-1 or HIV-2) antibodies.
- History of drug abuse within the past 12 months prior to screening.
- Despite guidance from the researcher, the participan is still unable to cooperate in completing the Respiratory Intensity and Impact Questionnaire (RiiQ)
- Participants may not be able to complete the study for other reasons, or may be deemed unsuitable for inclusion by the researcher.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
China-Japan Friendship Hospital
Beijing, Beijing Municipality
+86-010-84206264
About this study
Official title: 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
Read the 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
- Conditions
- Respiratory Syncytial Virus (RSV)
- Being tested
- YKYY018 for Inhalation Solution, YKYY018 Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YKYY018 for Inhalation SolutionDrug
nebulized inhalation, QD or Q2D of the corresponding dose of YKYY018 for inhalation solution
YKYY018 PlaceboDrug
nebulized inhalation, QD or Q2D of the corresponding dose of YKYY018 placebo
| Study group | Role | What they receive |
|---|---|---|
| YKYY018 group | Active comparator | Not described Receives: Drug: YKYY018 for Inhalation Solution |
| YKYY018 Placebo group | Placebo comparator | Not described Receives: Drug: YKYY018 Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The time from initial administration to symptom relief of lower respiratory symptoms on the RiiQ (Respiratory Intensity and Impact Questionnaire) symptom scale
Measured: within 28 days after administration
Secondary outcomes (3)
Adverse events(AEs)
Measured: within 28 days after administration
Serious adverse events (SAEs)
Measured: 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)
Measured: within 28 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start10 Oct 2026 (estimated)
- Primary completion10 Dec 2027 (estimated)
- Study completion10 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Syncytial Virus (RSV)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07808268
- Sponsor's protocol ID
- CLSP-YKYY018-Z03
- Status last verified
- Sep 2026
- First submitted
- 2 Sep 2026
- Last updated
- 8 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07808268
- Acronym / sponsor ID
- CLSP-YKYY018-Z03
- Conditions
- Respiratory Syncytial Virus (RSV)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Oct 2026 (estimated)
- Primary completion
- 10 Dec 2027 (estimated)
- Study completion
- 10 Mar 2028 (estimated)
- First posted
- 8 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A phase II clinical study to evaluate the efficacy and safety of YKYY018 for inhalation solution in adult participants with respiratory syncytial virus infection
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| YKYY018 group | Active comparator | Drug: YKYY018 for Inhalation Solution |
| YKYY018 Placebo group | Placebo comparator | Drug: YKYY018 Placebo |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (20 listed)
- 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.
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YKYY018 for Inhalation Solutionnebulized inhalation, QD or Q2D of the corresponding dose of YKYY018 for inhalation solution | Drug | YKYY018 group |
| YKYY018 Placebonebulized inhalation, QD or Q2D of the corresponding dose of YKYY018 placebo | Drug | YKYY018 Placebo group |
Primary outcome
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
3 secondary outcomes
Adverse events(AEs)
Time frame: within 28 days after administration
Serious adverse events (SAEs)
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing YKYY018 for Inhalation Solution in people with Respiratory Syncytial Virus (RSV), run by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuting Zhou (+86 18606417018, zhouyuting@bjykkc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.