A polycyclic compound having nitrogen-containing heterocycles. for Respiratory syncytial virus infection

Inclusion criteria

• {"criterion_text":"- Age 1. Participant must be ≥ 18 years of age (or the minimum age of informed consent if the minimum age of informed consent determined by local regulations is >18 years) at the time of screening."}
• {"criterion_text":"- Type of Participant and Disease Characteristics 3. Participants diagnosed with RSV infection preferably using a rapid polymerase chain reaction (PCR) or other molecular-based diagnostic assay. Note: If a participant had a positive RSV test result using a molecular-based diagnostic assay from another study for which he/she was otherwise ineligible or from a standard-of-care molecular-based diagnostic test within 72 hours prior to start of screening and meets all eligibility criteria for inclusion in this study, this diagnostic test result can be used for determination of eligibility. 5. With the exception of the RSV disease, medically stable on the basis of medical history, physical examination, vital signs, and 12-lead ECG performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and/or the RSV infection."}
• {"criterion_text":"- Sex and Contraceptive/Barrier Requirements The following criteria apply to male and female participants: 6. Contraceptive use by men or women should be consistent with local regulations regarding the use of contraceptive methods for those participating in clinical studies. Men must refrain from semen donation a. Male participants: Male participants are eligible to participate if they agree to the following during the intervention period and for at least 10 days after the last dose of investigational intervention: ● Refrain from donating fresh unwashed semen PLUS either: ● Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent OR ● Must agree to use contraception/barrier as detailed below – Agree to use a male condom when having sexual intercourse with a woman of childbearing potential who is not currently pregnant – Agree to use a male condom when engaging in any activity allowing for passage of ejaculate to another person"}
• {"criterion_text":"- Informed Consent 7. Capable of giving signed informed consent as described in Appendix 1 (Section 10.1.3), which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. Each participant has signed an ICF indicating he/she: a. Understands the purpose of, and procedures required for, the study b. Is willing and able to adhere to the prohibitions and restrictions with respect to the concomitant medication c. Is willing and able to adhere to the study procedures and assessments to be performed"}

Exclusion criteria

• {"criterion_text":"- 1. Hospitalized or expected to be hospitalized within 24 hours of screening. Any stay in the emergency room or in the observational unit of at least 24 hours will be considered hospitalization for the purposes of the study."}
• {"criterion_text":"- Prior/Concomitant Therapy 13. Has received a therapy intended to treat RSV infection (eg, ribavirin, traditional Chinese medicines, or complementary therapies) within 14 days prior to screening"}
• {"criterion_text":"- 14. Is receiving chemotherapy or immunotherapy for malignancy"}
• {"criterion_text":"- 15. Has received RSV vaccination within 7 days prior to screening Note: RSV vaccination is not prohibited, unless administered within 7 days prior to screening."}
• {"criterion_text":"- Prior/Concurrent Clinical Study Experience 16. The participant is currently participating or planned to participate in another clinical interventional study, during their participation in this study."}
• {"criterion_text":"- Diagnostic Assessments 17. Has had either confirmed SARS-CoV-2 or influenza infection (test was positive) during the 28 days prior to screening,"}
• {"criterion_text":"- 18. Has any other confirmed clinically relevant respiratory infection by any pathogen at, or within 28 days of screening"}
• {"criterion_text":"- Other Exclusion Criteria 19. Women who are of childbearing potential"}
• {"criterion_text":"- 20. Men who plan to father a child while enrolled in this study or within 10 days after the last dose of study intervention"}
• {"criterion_text":"- 21. Participants unable to take medications orally or with a known gastrointestinal-related condition considered by the sponsor or investigator to be likely to interfere with study intervention ingestion or absorption"}
• {"criterion_text":"- 22. Participants unwilling to undergo nasal nasopharyngeal swab procedures or with any physical abnormality which limits the ability to collect regular nasal specimens"}
• {"criterion_text":"- 2. Is considered by the investigator to be immunocompromised, due to an underlying medical condition (eg, HIV infection, malignancy, or genetic disorder other than immunoglobulin A deficiency) or medical therapy (eg, immunomodulators other than corticosteroids for the treatment of COPD or asthma exacerbations), chemotherapy, radiation, stem cell or solid organ transplant"}
• {"criterion_text":"- 23. At the US sites, site staff and their families who are directly involved in the conduct of the study, site staff who are otherwise under the supervision of the investigator, and sponsor and sponsor representative employees and their families who are directly involved in the conduct of this study. For sites in all other countries, apply local country regulations."}
• {"criterion_text":"- 3. Major surgery within 28 days prior to enrolment in the study or planned major surgery during the study"}
• {"criterion_text":"- 4. Has a neuromuscular disease affecting swallowing or the thoracic muscles"}
• {"criterion_text":"- 5. Has a known or clinically suspected acute or chronically active hepatitis B or C infection"}
• {"criterion_text":"- 6. Has known allergies, hypersensitivity, or intolerance to S-337395 or to any of the excipients of the S-337395 or placebo formulation"}
• {"criterion_text":"- 7. Suspicion or known severe renal impairment (defined as estimated glomerular filtration rate < 30 mL/min/1.73 m2) or ongoing dialysis"}
• {"criterion_text":"- 8. Aspartate aminotransferase or alanine aminotransferase > 3 times the upper limit of normal (ULN) or total bilirubin ≥ 2 × ULN (except for Gilbert syndrome) within the past 3 months, active liver disease (except direct bilirubin > ULN), or the presence of liver dysfunction grade B or C according to the Child-Pugh classification"}
• {"criterion_text":"- 9. Any other medical or psychiatric condition making the participant unsuitable for the current study or interfering with the evaluation of response to the study intervention in the opinion of the investigator/subinvestigator"}

Primary endpoints

• {"endpoint_text":"- Change from baseline in RSV RNA load by qRT-PCR (nasopharyngeal swab) on visit 2 (day 2), visit 3 (day 4), and visit 4 (day 6)","definition_or_measurement_approach":"Measured as change from baseline in RSV RNA load using qRT-PCR on nasopharyngeal swab samples at visit 2 (day 2), visit 3 (day 4) and visit 4 (day 6)."}

Secondary endpoints

• {"endpoint_text":"- Assessment of TEAEs, clinical laboratory test results, 12-lead ECGs, physical examination findings, and vital signs measurements","definition_or_measurement_approach":"Safety assessments including treatment-emergent adverse events (TEAEs), clinical laboratory tests, 12-lead ECGs, physical exam findings and vital signs measurements."}
• {"endpoint_text":"- Change from baseline over time in severity of RSV symptoms using RiiQ™: respiratory (RiiQ-RSS), systemic (RiiQ-SSS), and total (RiiQ-RSS + RiiQ-SSS). Time to resolution defined as return to baseline per PSQ. Includes time to first and sustained (2 days) resolution of respiratory, systemic, and combined symptoms, and resolution of each symptom separately, based on RiiQ subscales.","definition_or_measurement_approach":"Patient-reported symptom severity measured by RiiQ™ subscales (respiratory, systemic, total); time to first and sustained (2 days) resolution defined as return to baseline per PSQ."}
• {"endpoint_text":"- Based on RSV virological assay (nasopharyngeal swabs): Change from baseline in RSV RNA load and infectious titer at each time point; AUC through day 6; time to first/sustained negative or ","definition_or_measurement_approach":"Virological assessments from nasopharyngeal swabs including change from baseline in RNA load, infectious titer at each time point, area under the curve (AUC) through day 6, and time to first/sustained negative result by qRT-PCR."}
• {"endpoint_text":"- > Plasma concentrations of S-337395 after repeated oral doses of S-337395 > Plasma concentrations of S 337395 12 and 24 hours after the first dose and the last dose (C12 and C24)","definition_or_measurement_approach":"Pharmacokinetic measurements: plasma concentrations of S-337395 after repeated oral dosing including concentrations at 12 and 24 hours after first and last dose (C12 and C24)."}

Bulgaria

Earliest CTIS Part Ii Submission Date

06-11-2025

Latest Decision Or Authorization Date

18-11-2025

Processing Time Days

12

Number Of Sites

5

Number Of Participants

15

Poland

Earliest CTIS Part Ii Submission Date

28-11-2025

Latest Decision Or Authorization Date

13-03-2026

Processing Time Days

105

Number Of Sites

3

Number Of Participants

4

Primary sponsor

Full Name

Shionogi B.V.

Organisation Type

Pharmaceutical company

Country Of Registered Address

Netherlands

Contract research organisations

Name

PPD Global Limited

Responsibilities

codes: 1,10,12,13,2,4,5,6,7,8,9

Name

PPD Development LP

Responsibilities

codes: 4

Name

Pharmaceutical Product Development LLC

Responsibilities

codes: 4

Name

Cmic Pharma Science Co. Ltd.

Responsibilities

codes: 4

Name

ViroClinics Biosciences B.V.

Responsibilities

codes: 4

Name

4g Clinical LLC

Responsibilities

codes: 3

Name

Almac Clinical Services Limited

Responsibilities

codes: 14

Name

PPD Global Central Labs

Responsibilities

codes: 4

Third parties

• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"ePRO; codes: 15,7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"PPD Global Limited","duties_or_roles":"codes: 1,10,12,13,2,4,5,6,7,8,9","organisation_type":"Pharmaceutical company"}
• {"country":"Japan","full_name":"Cmic Pharma Science Co. Ltd.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Netherlands","full_name":"ViroClinics Biosciences B.V.","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"4g Clinical LLC","duties_or_roles":"codes: 3","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Clinical Services Limited","duties_or_roles":"codes: 14","organisation_type":"Pharmaceutical company"}
• {"country":"Belgium","full_name":"PPD Global Central Labs","duties_or_roles":"codes: 4","organisation_type":"Pharmaceutical company"}