RecruitingPhase 2NCT07214571

A Study of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus (RSV) Who Are at High Risk of Progression to Severe Disease

A Phase 2b, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Safety, Tolerability, and Efficacy of S-337395 in Symptomatic Nonhospitalized Adults With Respiratory Syncytial Virus Who Are at High Risk of Progression to Severe Disease

Sponsor

Shionogi

Enrollment

192 participants

Start Date

Dec 11, 2025

Study Type

INTERVENTIONAL

Conditions

Respiratory Syncytial Virus Infections

Summary

The main purpose of this study is to investigate the antiviral effect of S-337395 compared with placebo among nonhospitalized adult participants with high-risk factors for progression to severe RSV infection starting intervention within 72 hours of RSV symptom onset.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Placebo and a drug called S-337395 for people with respiratory syncytial virus infections. The study is currently recruiting participants at 80 locations. People eligible for this study include aged 18 Years and older.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGS-337395

S-337395 will be administered per schedule specified in the arm description.

DRUGPlacebo

Placebo matched to S-337395 will be administered per schedule specified in the arm description.

Locations(80)

LA Universal Research Center, Inc.

Los Angeles, California, United States

Med Partnes, Inc - Elligo- PPDS

Toluca Lake, California, United States

Hope Clinical Trials - 3970 W Flagler St.

Coral Gables, Florida, United States

Beautiful Minds Clinical Research Center

Cutler Bay, Florida, United States

Doral Medical Research

Hialeah, Florida, United States

Southern Clinical Research

Miami, Florida, United States

LCC Medical Research - Miami - BTC - PPDS

Miami, Florida, United States

Global Health Clinical Trials

Miami, Florida, United States

Nuren Medical and Research Center

Miami, Florida, United States

Continental Clinical Research, LLC

Miami, Florida, United States

Dynamic Medical Research, LLC - Miami

Miami, Florida, United States

Miami Clinical Research, LLP.

Miami, Florida, United States

Reed Medical Research

Miami, Florida, United States

Palm Springs Community Health Center

Miami Lakes, Florida, United States

Oceanic Research Group, LLC

North Miami Beach, Florida, United States

CDC Research Institute, LLC

Port Saint Lucie, Florida, United States

Cordova Research Insittute

Sweetwater, Florida, United States

Better Life Clinical Research LLC

Tampa, Florida, United States

Research Bay,Inc.

Tampa, Florida, United States

Santos Research Center - 5927 Webb Rd

Tampa, Florida, United States

Angels Clinical Research Institute Tampa-Palm Springs

Tampa, Florida, United States

Covenant Pulmonary Criticial Care and Research Ins

East Point, Georgia, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Clay Platte Family Medicine - CCT Research

Kansas City, Missouri, United States

NYC Health + Hospitals/Lincoln Medical Center - BRANY - PPDS

The Bronx, New York, United States

Prime Global Research, Inc.

The Bronx, New York, United States

Progressive Medicine of the Triad, LLC

Winston-Salem, North Carolina, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Epic Medical Research - Chickasha

Chickasha, Oklahoma, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Epic Med. Research LLC, DeSoto

DeSoto, Texas, United States

SMS Clinical Research, LLC - 400 W. Kearney St

Mesquite, Texas, United States

Clinical Research Partners LLC

Richmond, Virginia, United States

Frontier Clinical Research Waterfront

Morgantown, West Virginia, United States

Fundación Huésped - PPDS

CABA, Buenos Aires, Argentina

Instituto Médico Río Cuarto

Río Cuarto, Córdoba Province, Argentina

AES - AS - Clinica Mayo de Urgencias

San Miguel de Tucumán, Tucumán Province, Argentina

Medical Center Hera EOOD, Montana

Montana, Sofia, Bulgaria

Multiprofile Hospital For Active Treatment Dr Tota Venkova - PRATIA - PPDS

Gabrovo, Bulgaria

MCpulmo-2018 Ltd

Haskovo, Bulgaria

Medical Center Hera EOOD

Sofia, Bulgaria

Medical Center Neuromedics EOOD - 4 Veliki Preslav Str

Veliko Tarnovo, Bulgaria

Kamezawa Clinic

Kasugai-Shi, Aiti, Japan

Hosokawa Surgical Clinic

Nagoya-Shi Nakamura-Ku, Aiti, Japan

Doi Clinic

Chikushino-shi, Fukuoka, Japan

Irie Clinic

Fukuoka, Fukuoka, Japan

Tomita Internal Medicine Clinic

Fukuoka-Shi Chuo-Ku, Fukuoka, Japan

PS Clinic

Fukuoka-Shi Hakata-Ku, Fukuoka, Japan

Medical corporation Aimeikai Morizono internal medicine

Kitakyushu-Shi Yahatanishi-Ku, Fukuoka, Japan

Social Medical Corporation the Chiyukai foundation Shin Komonji Hospital

Kitakyushu-Shi, Fukuoka, Japan

Shizuka Clinic

Takasaki-shi, Gunma, Japan

Social medical corporation Keiwakai Nishioka Hospital

Sapporo-Shi Toyohira-Ku, Hokkaidô, Japan

Terada Internal Medicine and Respiratory Department

Himeji-shi, Hyôgo, Japan

Tsuchiura Beryl Clinic

Tsuchiura-Shi, Ibaraki, Japan

Gajyumaru Clinic Tsukuba

Tsukuba, Ibaraki, Japan

Shiwa Central Pediatrics

Shiwa-gun, Iwate, Japan

Medical corporation Kojinkai Takahashi Internal Medicine

Kawasaki-Shi, Kanagawa, Japan

Ebino Centro Clinic

Ebino, Miyazaki, Japan

Rinku General Medical Center

Izumisano, Osaka, Japan

Yamaichi Building Internal Medicine Clinic

Adachi-Ku, Tokyo, Japan

Medical Corporation Hosoda Clinic

Katsushika-ku, Tokyo, Japan

Medical Corporation Shirayurikai Swing Building Nozaki Clinic

Musashino, Tokyo, Japan

Nogata Clinic

Nakano-ku, Tokyo, Japan

Noguchi Internal Medicine Clinic

Nakano-Ku, Tokyo, Japan

Sato Clinic

Shibuya-Ku, Tokyo, Japan

Mih Clinic Yoyogi

Shibuya-Ku, Tokyo, Japan

Medical corporation Hiroyukai Yotsuya Internal Medicine

Shinjuku-Ku, Tokyo, Japan

Yoshida Clinic

Suginami-ku, Tokyo, Japan

Sekino Hospital

Toshima-Ku, Tokyo, Japan

Kijima Kids Clinic

Higashiokitama-gun, Yamagata, Japan

Toda Internal Medicine and Neurology

Hyōgo, Japan

Alergo-Med Osrodek Badan Klinicznych sp z o.o

Tarnów, Lesser Poland Voivodeship, Poland

Centrum Medyczne Chojnice - PRATIA - PPDS

Chojncie, Pomeranian Voivodeship, Poland

Ostrowieckie Centrum Medyczne Spólka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik

Ostrowiec Świętokrzyski, Świętokrzyskie Voivodeship, Poland

Newtown Clinical Research Centre

Johannesburg, Gauteng, South Africa

Roodepoort Medicross Clinical Research Centre

Princess Crossing, Roodepoort, South Africa

Be Part Yoluntu Centre

Paarl, Western Cape, South Africa

The Aurum Institute Rustenburg Clinical Research Site

Rustenburg, South Africa

Kaohsiung Veterans General Hospital

Kaohsiung City, Taiwan

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

View Full Details on ClinicalTrials.gov

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NCT07214571

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