A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus

PHASE2CompletedINTERVENTIONAL
Enrollment

72

Participants

Timeline

Start Date

February 6, 2018

Primary Completion Date

November 27, 2019

Study Completion Date

December 26, 2019

Conditions
Respiratory Syncytial Virus Infections
Interventions
DRUG

JNJ-53718678 500 mg

Participants will receive 500 mg dose of JNJ-53718678 oral solution once daily for 7 days.

DRUG

JNJ-53718678 80 mg

Participants will receive 80 mg dose of JNJ-53718678 oral solution along with the matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

DRUG

Placebo

In treatment B, participants will receive matching placebo along with JNJ-53718678 to maintain the same total volume as for the 500 mg dose once daily for 7 days. In treatment C, participants will receive matching placebo to the same total volume as for the 500 mg dose once daily for 7 days.

Trial Locations (124)

220

Far Eastern Memorial Hospital, Taipei

437

Kuang Tien General Hospital- Dajia, Taichung

1000

CHU Saint-Pierre, Brussels

1431

Diagnostic Consultation Centre 'Alexandrovska' EOOD, Sofia

1702

HIGA Prof. Dr. Ramón Carrillo, Ciudadela

1818

Soweto Clinical Trial Centre, Johannesburg

2000

Specialized Hospital for Active Treatment of Pulmonary Diseases - Pernik, Pernik

2001

Newtown Clinical Research, Johannesburg

2059

Paratus Clinical Kanwal Clinic, Kanwal

2060

Paratus Clinical Blacktown Clinic, Blacktown

2145

Westmead Hospital, Sydney

3010

Hosp. Gral. Univ. de Alicante, Alicante

3203

Hosp. Gral. Univ. de Elche, Elche

3220

Barwon Health - University Hospital Geelong, Geelong

3320

MHAT 'Sv. Ivan Rilski' Kozloduy EOOD, Kozloduy

3945

Jaak Mortelmans, Ham

3980

Testumed, Tessenderlo

4021

Paratus Clinical Kippa Ring Clinic, Kippa-Ring

4101

Mater Hospital Brisbane, South Brisbane

4703

MHAT 'Dr. Bratan Shukerov', Smolyan

5000

Hospital Rawson, Córdoba

5600

Specialized Hospital for Active Treatment of Pulmonary Diseases - Troyan EOOD, Troyan Municipality

7002

SHAT of Pneumo-phthisiatric Diseases Dr Dimitar Gramatikov - Ruse, EOOD, Rousse

7061

Seoul Metropolitan Government Seoul National University Boramae Medical Center, Seoul

8000

Hospital Espanol De Bahia Blanca, Bahía Blanca

8332

Sanatorio Juan XXIII, General Roca

9230

BVBA Dr. Luc Capiau, Massemen

9460

Welkom Clinical Trial Centre, Welkom

11696

Taipei Municipal Wanfang Hospital, Taipei

12203

MECS GmbH, Berlin

14584

Soonchunhyang University Bucheon Hospital, Bucheon-si

15706

Hosp. Clinico Univ. de Santiago, Santiago de Compostela

16247

The Catholic university of Korea, St. Vincent's Hospital, Gyeonggi-do

18014

Hosp. Univ. Virgen de Las Nieves, Granada

20230

Hospital Cardiologica Aguascalientes, Aguascalientes

20502

Skanes universitetssjukhus, Malmo

21001

Private Small Enterprise Medical Center Pulse, Vinnytsia

21009

Medical Center Ltd 'Health Clinic', Department Of General Therapy, Vinnytsia

21021

Vinnytsia City Clinical Hospital #1, Vinnytsia National Medical University, Vinnytsia

21565

Gachon University Gil Hospital, Incheon

22322

Inha University Hospital, Incheon

23554

Hausarztpraxis am Lindenplatz, Lübeck

23561

Taipei Medical University Shuang Ho Hospital, New Taipei City

28006

Hosp. Univ. de La Princesa, Madrid

28277

Onsite Clinical Solutions, Charlotte

29301

Fusion Clinical Research of Spartanburg, Spartanburg

29341

Spectrum Medical Research, Gaffney

30159

Klinische Forschung Hannover-Mitte GmbH, Hanover

32726

Lake Internal Medicine Associates, Eustis

33174

Florida Research Center Inc., Miami

36213

Hosp. Alvaro Cunqueiro, Vigo

41944

Kyungpook National University Hospital, Daegu

44093

CHU Nantes - Hotel Dieu, Nantes

44130

Centro de Investigacion Medico Biologica y Terapia Avanzada CIMBYTA, Guadalajara

44280

Hospital Civil de Guadalajara Fray Antonio Alcalde, Guadalajara

44300

Cabinet du Dr Boye, Nantes

47923

Centre Hospitalier d'Agen, Agen

48073

William Beaumont Hospital, Royal Oak

49000

Cabinet du Dr Remaud, Angers

49610

Maison Medicale Rive Sud, Mûrs-Erigné

55407

AllinaHealth - Abbott Northwestern Hospital (13520), Minneapolis

59701

Mercury Street Medical Group, PLLC, Butte

60596

IKF Pneumologie GmbH & Co. KG Am Standort IFS - Interdisziplinäres Facharztzentrum, Frankfurt

61103

Medical Center of LL Company 'Scientific Medical Center-Your Doctor', Kharkiv

61106

Medical Unit Of Company 'Kharkiv Tractor Plant', Kharkiv Medical Academy Of Postgraduate Education, Kharkiv

64460

Hospital Universitario de Nuevo Leon 'Dr Jose Eleuterio Gonzalez', Monterrey

73000

Mi 'Kherson City Clinical Hospital Of E.E. Karabelesh', Kherson

73052

Unity Clinical Research, Lindsay

75020

Cabinet du Dr Baranes, Paris

75185

Akademiska Sjukhuset, Uppsala

81362

Kaohsiung Veterans General Hospital, Kaohsiung City

83686

Family Medicine, Nampa

90185

Norrlands Universitetssjukhus, Umeå

90703

Core Healthcare Group, Cerritos

92844

SC Clinical Research Inc, Garden Grove

143408

Krasnogorsk city hospital #1, Krasnogorsk

193312

City Polyclinic #25 of the Nevsky District of SPB, Saint Petersburg

194354

LLC 'Medical centr 'Reavita Med Spb', Saint Petersburg

196143

Eco-safety Ltd, Saint Petersburg

197376

Research Institute of Influenza, Saint Petersburg

919111

eStudySite, Chula Vista

B8001DDU

Hospital Interzonal General de Agudos Dr. Jose Penna, Bahía Blanca

X5016KEH

Hospital Privado - Centro Medico de Cordoba, Barrio Parque Velez Sarfield

C1426ABP

Fundación Respirar, CABA

B1900AX

Hospital Italiano de La Plata, Ciudad de La Plata

X5004BAL

Hospital Italiano de Cordoba, Córdoba

X5004CDT

Hospital Cordoba, Córdoba

S2000DEJ

Instituto Médico de la Fundación de Estudios Clínicos (ECLIN), Rosario

T4000IHE

Clinica Mayo de UMCB, San Miguel de Tucumán

30150-221

Santa Casa de Misericordia de Belo Horizonte, Belo Horizonte

18618-970

Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu), Botucatu

88036-800

Universidade Federal de Santa Catarina, Florianópolis

59025-050

Centro de Estudos e Pesquisas em Moléstias Infecciosas - CEPCLIN, Natal

99010-080

Associacao Hospitalar Beneficente Sao Vicente de Paulo - Hospital Sao Vicente de Paulo, Passo Fundo

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS, Porto Alegre

40110-060

Universidade Federal da Bahia - Hospital Professor Edgard Santos, Salvador

01308 901

Sociedade Beneficente de Senhoras - Hospital Sírio Libanês, São Paulo

01421-000

Hospital Alemao Oswaldo Cruz, São Paulo

04231-030

Hospital Heliopolis, São Paulo

L6T 0G1

Aggarwal and associates Ltd, Brampton

N5W 6A2

Milestone Research, London

M9V 4B4

Dr Anil K Gupta Medicine Professional Corporation, Toronto

H1M 1B1

Clinique Force Medic (GCP Trials), Montreal

910-0067

Fukui General Clinic, Fukui-shi

210-0852

Koukan Clinic, Kawasaki

800-0057

Shinkomonji hospital, Kitakyushu

184-0004

Musashikoganei Clinic, Koganeishi

862-0976

Medical Square Kuhonji Clinic, Kumamoto

598-8577

Rinku General Medical Center, Osaka

140-8522

Tokyo Shinagawa Hospital, Shinagawa-ku

359-1141

Saino Clinic, Tokorozawa-shi

470-0396

Toyota Kosei Hospital, Toyota

824-0026

Shin Yukuhashi Hospital, Yukuhashi

03100

RM Pharma Specialists, México

25-751

Indywidualna Specjalistyczna Praktyka Lekarska Lek. Krzysztof Lis, Kielce

30 033

Centrum Medyczne All Med, Krakow

31 559

Diamond Clinic, Krakow

90-141

SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im.Barlickiego Uniwersytetu Med. w Lodzi Zespol Poradni, Lodz

63-400

Beata Asankowicz-Bargiel i Partnerzy, Lekarze-sp. Spec. Poradnia Pulmonologiczna, Ostrów Wielkopolski

51-162

Centrum Badan Klinicznych, Osrodek Badan Wczesnej Fazy, Wroclaw

0002

Emmed Research, Pretoria

07441

Kangnam Sacred Heart Hospital, Seoul

03049

Kyiv Railway Clinical Hospital #2 Of Branch 'Health Center' Of The Company 'Ukrainian Railway', Kyiv

04050

Policlinic of State Joint Stock Holding Company 'Artem', Kyiv

All Listed Sponsors
lead

Janssen Research & Development, LLC

INDUSTRY

NCT03379675 - A Study to Explore the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of JNJ-53718678 at Two Dose Levels in Non-Hospitalized Adult Participants Infected With Respiratory Syncytial Virus | Biotech Hunter | Biotech Hunter