Respiratory Syncytial Virus (RSV) Infection MedDRA version: 20.0 Level: PT Classification code 10061603 Term: Respiratory syncytial virus infection System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Product Name: ALS-008176
Product Code: ALS-008176
Pharmaceutical Form: Powder for oral suspension
INN or Proposed INN: N/A
CAS Number: P
Sponsors
Janssen Research & Development, LLC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subject’s parent(s)/legal guardian(s) has provided signed and dated informed consent and authorization to use protected health information, as required by national and local regulations. 2) In the investigator’s opinion, the subject’s parent(s)/legal guardian(s) understands and is able to comply with protocol requirements, instructions, and protocol-stated restrictions, and is likely to complete the study as planned. 3) Male or female infant who • is = 1.0 to = 12.0 months of age (inclusive), defined at the time of hospital admission or =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) History of or concurrent clinically significant medical illness (not directly attributable to the acute RSV infection) – including, but not limited to cardiovascular, respiratory, renal, gastrointestinal, hematologic, neurologic, endocrinologic, immunologic, musculoskeletal, oncologic, or congenital disorders – as judged by the Investigator. Specifically excluded conditions include but are not limited to: a. Immunosuppressed state b. Bronchopulmonary dysplasia c. Congenital heart disease d. Down’s syndrome 2) Prematurity, defined as gestational age 14 days for neonates and infants 28 days for subjects =2-=12 months of age) or within the 21 days prior to randomization) which are known to modulate the host immune response and/or increase viral shedding such as corticosteroids or other immunomodulatory therapies. The only exception is systemic corticosteroids will be acceptable if they are not taken chronically for a non-RSV-related indication. ? Prescription medications used within 14 days prior to randomization to treat the RSV infection itself (e.g., ribavirin, intravenous immunoglobulin). Prescription medications intended to treat the symptoms/sequelae of the RSV infection are permitted. ? Prescription medications which are known to be strong inhibitors of the OAT3 transporter, within 21 days prior to randomization c. Investigational drug trial medications within 30 days or 5 half-lives (whichever is longer) prior to randomization
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety and tolerability of single and multiple doses of ALS-008176;Primary end point(s): Safety data including, but not limited to, adverse events, physical examinations, vital signs, 12-lead ECGs and clinical laboratory results (including chemistry and hematology); Timepoint(s) of evaluation of this end point: SAD: Post randomisation, Study days 2 to 6 and Completion visit day 7 MAD: Post randomisation, Study days 2 to 10, Outpatient safety visit and Completion day 11. ; Secondary Objective: • To evaluate the pharmacokinetics of ALS-008112 and ALS-008144 (and other metabolites, if applicable) in blood following single and multiple doses of ALS-008176 • To evaluate the antiviral activity of ALS-008176 after single and multiple doses of ALS-008176 • To determine if ALS-008176 exposure results in the emergence of resistant strains of RSV | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): PK parameters of ALS-008112 and ALS-008144 (and other metabolites, as applicable) in blood following single dose administration: Cmax, tmax, t1/2, AUC0-24h, AUC0-inf or AUC0-last PK parameters of ALS-008112 and ALS-008144 (and other metabolites as applicable) in blood following repeat dose administration: Cmax, Cmin, tmax, t1/2, AUC0-12h, AUC0-24h, AUC0-tau, AUC0-inf or AUC0-last RSV viral RNA concentrations in nasal swabs or aspirates as measured by quantitative RT-PCR Changes in the RSV polymerase that result in reduced sensitivity to ALS-008112 ; Timepoint(s) of evaluation of this end point: SAD: Post randomisation, Study days 2 to 6 and Completion visit day 7 MAD: Post randomisation, Study days 2 to 10, Outpatient safety visit and Completion day 11. | — |
Countries
Australia, Canada, Chile, Colombia, France, Japan, New Zealand, Panama, Romania, South Africa, Taiwan, Thailand, United Kingdom, United States
Contacts
Public ContactNone
Janssen Research & Development, LLC
Outcome results
None listed