ClinicalTrials.gg
Not yet recruitingNCT07808268Updated Sep 8, 2026

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

A Phase 2 interventional study of YKYY018 for Inhalation Solution and YKYY018 Placebo in Respiratory Syncytial Virus (RSV), sponsored by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-09-08.

Sponsored by Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. (part of Youcare Pharmaceutical Group Co., Ltd.) · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 85 Years
Sex
All
01

Study 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 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

02

Conditions studied

  • Respiratory Syncytial Virus (RSV)
03

In context

Lead sponsor

Beijing Youcare Kechuang Pharmaceutical Technology Co., Ltd. is the lead sponsor of 5 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Participant must voluntarily consent to participate in this study and provide their written 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 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

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 or ).
  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 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 (ALT), aspartate aminotransferase (AST) levels greater than 2 times the (ULN), total levels greater than 1.5 times ULN, or serum creatinine levels greater than 1.5 times ULN, or other laboratory test results that are 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 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 (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.
Terms in these criteria, in plain language(11)

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.

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.

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.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

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.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

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.

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.

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.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
160 participants (estimated)

Study arms

  • Active comparator
    YKYY018 group

    Drug: YKYY018 for Inhalation Solution

  • Placebo comparator
    YKYY018 Placebo group

    Drug: YKYY018 Placebo

Interventions

  • DrugYKYY018 for Inhalation Solution

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

  • DrugYKYY018 Placebo

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

06

What researchers measure

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

07

Study locations

1 site
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Dec 2027, 14 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 2, 2026
First posted
Sep 8, 2026
StartEst.
Oct 10, 2026
Primary completionEst.
Dec 10, 2027
CompletionEst.
Mar 10, 2028
Last update
Sep 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07808268
Responsible party
Sponsor
First posted
Sep 8, 2026
Start date
Oct 10, 2026 (estimated)
Primary completion
Dec 10, 2027 (estimated)
Completion
Mar 10, 2028 (estimated)
Last update
Sep 8, 2026

Study contacts

Yuting Zhou
Contact
zhouyuting@bjykkc.com
+86 18606417018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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