A Study to Assess the Pharmacokinetics, Safety, and Tolerability of Multiple Doses of Orally Administered JNJ-53718678 in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection

NCT ID: NCT02593851

Last Updated: 2019-12-06

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-04
• Study Completion Date: 2017-11-10

Brief Summary

The purpose of this study is to evaluate pharmacokinetics, safety, tolerability, antiviral activity, and impact on the clinical course of Respiratory Syncytial Virus (RSV) infection after multiple oral doses of JNJ-53718678 at different doses and/or dosing regimens in infants (greater than [>] 1 month to less than or equal to [<=] 24 months of age) who are hospitalized with RSV infection.

Detailed Description

This is a Phase 1b, randomized (study medication assigned to participants by chance), partially double-blind (neither physician nor participant knows the identity of the assigned treatment), placebo-controlled, multicenter, multiple ascending dose study of JNJ 53718678 in infants (greater than [>] 1 month to less than or equal to [<=] 24 months of age) who are hospitalized with RSV infection. The duration of study will be approximately 4 weeks for each participant excluding screening period. In Part 1 of study, minimum total number of 42 participants will be divided in 3 cohorts: Age group 1 (Cohorts 1a-1e) (greater than or equal to [>=] 6 months and less than or equal to [<=] 24 months of age), Age group 2 (Cohorts 2a-2e)(>=3 months and less than [<] 6 months of age) and Age group 3 (Cohorts 3a-3e) (greater than [>] 1 month and <3 months of age). Each age group will consist of a minimum of 3 cohorts with the possibility to add 2 more per age group (Cohorts a through e) in which different doses and/or dosing regimens will be evaluated. Each cohort will consist of 5 participants (4 participants receiving JNJ-53718678 and 1 participant receiving placebo for 7 days), except for the first cohort of each age group which will contain only 4 participants (4 participants receiving JNJ 53718678). In Part 2 of the study, all age groups will be included in a single cohort, Cohort f, in which the selected dose regimen determined during Part 1 of the study will be used for each of the 3 age groups. A minimum of approximately 18 (12 participants receiving JNJ 53718678 and 6 participants receiving placebo) and a maximum of 24 participants (16 participants receiving JNJ 53718678 and 8 participants receiving placebo) will be included in this part of the study. Pharmacokinetics and safety of JNJ-53718678 will be evaluated primarily. Participants' safety will be monitored throughout the study.

Conditions

Respiratory Syncytial Virus Infections; Virus Diseases

Keywords

Respiratory Syncytial Virus Infections; JNJ-53718678; Placebo; Infants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Part 1: Cohort 1a

Participants (greater than or equal to \[\>=\] 6 months and less than or equal to \[\<=\] 24 months of age) will receive JNJ-53718678, 2 milligram per kilogram body weight (mg/kg) oral solution once daily on Day 1 to Day 7. Dose and/or dosing regimen may be adapted in subsequent cohorts based on the review of the safety/tolerability and full pharmacokinetic data from Cohort 1a.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 1b

Participants (\>= 6 months and \<= 24 months of age) will receive total daily dose of 6 mg/kg JNJ-53718678 oral solution or placebo \[either in once daily \[qd\] or twice daily \[bid\]) on Day 1 to Day 7.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 1c

Participants (\>= 6 months and \<= 24 months of age) will receive total daily dose of 18 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 1d

Participants (\>= 6 months and \<= 24 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 1d is optional and may be included at the discretion of the sponsor.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 1e

Participants (\>= 6 months and \<= 24 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 1e is optional and may be included at the discretion of the sponsor.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 2a

Participants (\>= 3 months and less than \[\<\] 6 months of age) will receive total daily dose of 1.5 mg/kg JNJ-53718678 oral solution \[either in a qd or a bid regimen\] on Day 1 to Day 7.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 2b

Participants (\>=3 months and \< 6 months of age) will receive total daily dose of 4.5 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 2c

Participants (\>= 3 months and \< 6 months of age) will receive total daily dose of 13.5 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 2d

Participants (\>= 3 months and \< 6 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 2d is optional and may be included at the discretion of the sponsor.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 2e

Participants (\>= 3 months and \< 6 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 2e is optional and may be included at the discretion of the sponsor.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 3a

Participants (greater than (\>) 1 month and \< 3 months of age) will receive total daily dose of 1 mg/kg JNJ-53718678 oral solution \[either in a qd or a bid regimen\] on Day 1 to Day 7.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 3b

Participants (\> 1 month and \< 3 months of age) will receive total daily dose of 3 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 3c

Participants (\> 1 month and \< 3 months of age) will receive total daily dose of 9 mg/kg JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 3d

Participants (\> 1 month and \< 3 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 3d is optional and may be included at the discretion of the sponsor.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Part 1: Cohort 3e

Participants (\> 1 month and \< 3 months of age) will receive JNJ-53718678 oral solution or placebo \[either in a qd or a bid regimen\] on Day 1 to Day 7. The cohort 3e is optional and may be included at the discretion of the sponsor.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Part 2: Cohort f

Participants of all age groups will receive daily dose of JNJ-53718678 oral solution or placebo, either in a qd or a bid regimen on Days 1 to 7.

Group Type: EXPERIMENTAL

JNJ-53718678

Intervention Type: DRUG

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Placebo

Intervention Type: DRUG

Placebo oral solution will be administered once or twice daily for 7 days.

Interventions

JNJ-53718678

JNJ-53718678 oral solution will be administered once or twice daily for 7 days.

Intervention Type: DRUG

Placebo

Placebo oral solution will be administered once or twice daily for 7 days.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant has presented at the hospital for suspected Respiratory Syncytial Virus (RSV) infection within 72 hours prior to Screening completion
• Participant has been hospitalized for this suspected RSV infection
• Participant has been diagnosed with RSV infection using a polymerase chain reaction (PCR)-based assay, preferably commercially available locally
• Participant was born after a normal term pregnancy (greater than or equal to 37 weeks and 0 days)
• A legally acceptable representative of the participant must sign an Informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study, are willing for their child to participate in the study, are willing for their child to remain in the hospital for the first 3 days of dosing (even if not clinically indicated), and are willing/able to adhere to the prohibitions and restrictions specified in the protocol and study procedures

Exclusion Criteria

• Participant who had major surgery within the 28 days prior to randomization or planned major surgery through the course of the study
• Participant has major congenital anomalies or known cytogenetic disorders
• Participant has known or suspected immunodeficiency, such as known human immunodeficiency virus (HIV) infection
• Participant has known or suspected hepatitis B or C infection
• Participant is upon current admission initially hospitalized in the Intensive care unit (ICU) and/or in need of invasive endotracheal mechanical ventilation

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 24 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen Sciences Ireland UC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen Sciences Ireland UC Clinical Trial

Role: STUDY_DIRECTOR

Janssen Sciences Ireland UC

Locations

Kirksville, Missouri, United States

Bahía Blanca, , Argentina

City of Buenos Aires, , Argentina

Córdoba, , Argentina

Geelong, , Australia

Hobart, , Australia

Westmead, , Australia

Anderlecht, , Belgium

Brussels, , Belgium

Charleroi, , Belgium

Edegem, , Belgium

Leuven, , Belgium

Lier, , Belgium

Curitiba, , Brazil

Porto Alegre, , Brazil

Ribeirão Preto, , Brazil

Rio de Janeiro, , Brazil

São Paulo, , Brazil

Freiburg im Breisgau, , Germany

Hamm, , Germany

Heidelberg, , Germany

München, , Germany

Hoofddorp, , Netherlands

Utrecht, , Netherlands

Cebu City, , Philippines

Manila, , Philippines

Almería, , Spain

Barcelona, , Spain

Esplugues de Llobregat, , Spain

Getafe, , Spain

Madrid, , Spain

Málaga, , Spain

Santiago de Compostela, , Spain

Seville, , Spain

Valencia, , Spain

Gothenburg, , Sweden

Linköping, , Sweden

Lund, , Sweden

Malmo, , Sweden

Countries

South Africa; United States; Argentina; Australia; Belgium; Brazil; Germany; Netherlands; Philippines; Spain; Sweden

References

Martinon-Torres F, Rusch S, Huntjens D, Remmerie B, Vingerhoets J, McFadyen K, Ferrero F, Baraldi E, Rojo P, Epalza C, Stevens M. Pharmacokinetics, Safety, and Antiviral Effects of Multiple Doses of the Respiratory Syncytial Virus (RSV) Fusion Protein Inhibitor, JNJ-53718678, in Infants Hospitalized With RSV Infection: A Randomized Phase 1b Study. Clin Infect Dis. 2020 Dec 17;71(10):e594-e603. doi: 10.1093/cid/ciaa283.

Reference Type: DERIVED

PMID: 32201897 (View on PubMed)

Other Identifiers

2015-002003-28

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

53718678RSV1005

Identifier Type: OTHER

Identifier Source: secondary_id

CR107945

Identifier Type: -

Identifier Source: org_study_id