E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Respiratory Syncytial Virus |
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E.1.1.1 | Medical condition in easily understood language |
Respiratory Syncytial Virus |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.0 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10038717 |
E.1.2 | Term | Respiratory syncytial viral infections |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the antiviral effect of repeated oral dosing of JNJ-53718678 compared to placebo in healthy adult subjects infected through inoculation with RSV-A Memphis 37b virus. |
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E.2.2 | Secondary objectives of the trial |
- To evaluate the safety and tolerability of JNJ-53718678 compared to placebo after repeated oral dosing in healthy adult subjects inoculated with RSV-A Memphis 37b virus.
- To evaluate the pharmacokinetics of JNJ-53718678 after single and repeated oral dosing in healthy adult subjects inoculated with RSV-A Memphis 37b virus.
- To evaluate the relationship between the pharmacokinetics and the pharmacodynamics (viral load) after repeated oral dosing of JNJ-53718678 in healthy adult subjects infected through inoculation with RSV-A Memphis 37b virus.
- To evaluate the effect on clinical symptoms of RSV infection of JNJ-53718678 compared to placebo after repeated oral dosing in in healthy adult subjects infected through inoculation with RSV-A Memphis 37b virus.
See protocol for additional secondary objectives. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Female participants must be of non-childbearing potential: postmenopausal for at least 2 years or surgically sterile or otherwise incapable of becoming pregnant
- Female participants, except for postmenopausal women, must have a negative serum pregnancy test at screening - Participants must agree to comply with contraceptive measures as mentioned in protocol
- Participants must be sero-suitable for respiratory syncytial virus (RSV) within 57 days prior to inoculation
- Participants must be non-smokers for at least one month prior to screening and participants must have a negative cotinine test at screening |
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E.4 | Principal exclusion criteria |
- Participants with a past history of heart arrhythmias (extrasystoli, tachycardia at rest) or of risk factors for Torsade de Pointes syndrome - Participants with a history or evidence of abuse of alcohol, barbiturates, amphetamines, recreational or narcotic drug use within the past 3 months, which in the Investigator’s opinion would compromise participant’s safety and/or compliance with the study procedures
- Participants with current human immunodeficiency virus type 1 (HIV-1) or HIV-2 infection at screening
- Participants with current hepatitis A infection, or hepatitis B virus (HBV) infection, or hepatitis C virus (HCV) infection (confirmed by HCV antibody) at screening
- Participants with active acute respiratory infection at admission (Study Day -1 or -2) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Area Under the Viral Load-time Curve (VL AUC) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1 - Area Under the Viral Load-time Curve (VL AUC) Determined by Plaque Forming Unit (PFU) Assay
2 - Viral Load Over Time
3 - Peak Viral Load
4 - Time To Peak Viral Load
5 - Area Under the Viral Load-time Curve (VL AUC) From Time 0 to 24 Hours after First Dose
6 - Area Under the Viral Load-time Curve (VL AUC) From Time 0 to 48 Hours after First Dose
7 - Time to Non-detectability of Virus
8 - Total Clinical Symptom Score
9 - Time to Peak Symptom Score After Viral Inoculation
10 - Mucus Weight
11 - Tissue Count
12 - Sequence Analysis of the Rsv-A Memphis 37b Genome
13 - Forced Expiratory Volume in 1 Second (FEV1) Measured by Spirometry
14 - Forced Vital Capacity (FVC) Measured by Spirometry
15 - FEV1/FVC Ratio |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1 - Baseline up to Follow-up (Day 28)
2 - Baseline up to Follow-up (Day 28)
3 - Baseline up to Follow-up (Day 28)
4 - Baseline up to Follow-up (Day 28)
5 - 24 hours after first dose
6 - 48 hours after first dose
7 - Baseline up to Follow-up (Day 28)
8 - Admission (Day -1 or -2) up to Day 13
9 - Admission (Day -1 or -2) up to Day 13
10 - Baseline up to Day 13
11 - Baseline up to Day 13
12 - Baseline and post-Baseline
13 - Baseline up to Follow-up (Day 28)
14 - Baseline up to Follow-up (Day 28)
15 - Baseline up to Follow-up (Day 28) |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
- Tolerability
- Effect on mucus production
- Development of viral resistance |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 3 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |