A Study of ALS-008176 in Infants Hospitalized With RSV
NCT02202356 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 183
Last updated 2025-02-03
Summary
This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single and multiple doses of ALS-008176 in infants hospitalized with respiratory syncytial virus (RSV)
Conditions
- Respiratory Syncytial Virus Infections
Interventions
- DRUG
-
ALS-008176
- DRUG
Sponsors & Collaborators
-
Alios Biopharma Inc.
lead INDUSTRY
Principal Investigators
-
Matthew McClure, M.D. · Alios BioPharma
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Max Age
- 12 Months
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2014-07-23
- Primary Completion
- 2018-02-15
- Completion
- 2018-02-15
- FDA Drug
- Yes
Countries
- United States
- Australia
- Canada
- Chile
- Colombia
- France
- Japan
- New Zealand
- Panama
- Romania
- South Africa
- Taiwan
- Thailand
- United Kingdom
Study Locations
More Related Trials
-
A Study to Confirm the Effectiveness and Safety of AK0529 in Treating RSV Infections in Hospitalized Infants
NCT06775405 ·Status: RECRUITING ·Phase: PHASE3
-
Evaluating the Safety and Immune Response to a Single Dose of a Respiratory Syncytial Virus (RSV) Vaccine in RSV-Seronegative Infants and Children
NCT01852266 ·Status: COMPLETED ·Phase: PHASE1
-
Respiratory Syncytial Virus Human Challenge in Healthy Adult Volunteers
NCT02484417 ·Status: COMPLETED ·Phase: PHASE1
-
Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine, LID/ΔM2-2/1030s, in RSV-Seronegative Infants and Children 6 to 24 Months of Age
NCT04520659 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Describe the Safety and Immunogenicity of a RSV Vaccine in Healthy Adults
NCT03529773 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluating the Infectivity, Safety, and Immunogenicity of Recombinant Live-Attenuated RSV Vaccines RSV ΔNS2/Δ1313/I1314L or RSV 276 in RSV-Seronegative Infants 6 to 24 Months of Age
NCT03227029 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Vaccine Against Respiratory Syncytial Virus
NCT04519073 ·Status: COMPLETED ·Phase: PHASE1
-
Viral Inhibition in Children for Treatment of RSV
NCT02654171 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate the Safety and Ability of the Vaccine to Induce Antibodies Against the Respiratory Syncytial Virus in Healthy Adults
NCT02298179 ·Status: COMPLETED ·Phase: PHASE1
-
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety of MEDI-559 in Healthy 1 to <24 Month-Old Children
NCT00767416 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Safety and Immunogenicity of the RSV D46cpΔM2-2 Vaccine in RSV-Seropositive Children and RSV-Seronegative Infants and Children
NCT02601612 ·Status: COMPLETED ·Phase: PHASE1
-
Safety and Immunogenicity of a Single Dose of the Recombinant Live-Attenuated Respiratory Syncytial Virus (RSV) Vaccines RSV ΔNS2/Δ1313/I1314L, RSV 6120/ΔNS2/1030s, RSV 276 or Placebo, Delivered as Nose Drops to RSV-Seronegative Children 6 to 24 Months of Age
NCT03916185 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Phase 2b Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
NCT01065935 ·Status: COMPLETED ·Phase: PHASE2
-
Surveillance Study of Respiratory Syncytial Virus Infection (RSV) in Subjects < 24 Months of Age
NCT01754428 ·Status: COMPLETED
-
Intermittent Use of Aerosolized Ribavirin for Treatment of RSV
NCT00500578 ·Status: COMPLETED ·Phase: PHASE4
-
Evaluating the Infectivity, Safety and Immunogenicity of Respiratory Syncytial Virus Vaccines, RSV 6120/∆NS1 and RSV 6120/F1/G2/∆NS1, in RSV-Seropositive Children and RSV-Seronegative Infants and Children
NCT03596801 ·Status: COMPLETED ·Phase: PHASE1
-
Phase 2 Study of ALN-RSV01 in Lung Transplant Patients Infected With Respiratory Syncytial Virus (RSV)
NCT00658086 ·Status: COMPLETED ·Phase: PHASE2
-
A Study to Evaluate a Single Intravenous Dose of Motavizumab for the Treatment of Children Hospitalized With Respiratory Syncytial Virus (RSV) Illness
NCT00421304 ·Status: COMPLETED ·Phase: NA
-
Safety of and Immune Response to Recombinant Live Attenuated Parainfluenza Type 3 Virus Vaccine in Healthy Infants and Children
NCT01021397 ·Status: COMPLETED ·Phase: PHASE1
-
A Trial to Evaluate the Efficacy and Safety of TNM001 for the Prevention of Lower Respiratory Tract Infection Caused by Respiratory Syncytial Virus in Infants
NCT06083623 ·Status: COMPLETED ·Phase: PHASE2/PHASE3
-
A Study to Learn About the Effects of Sisunatovir in Infants With Respiratory Syncytial Virus Lower Respiratory Tract Infection.
NCT04225897 ·Status: TERMINATED ·Phase: PHASE2
-
A Study To Evaluate the Safety of XW001 Inhalation in Children With RSV
NCT05779995 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Evaluating the Infectivity, Safety and Immunogenicity of a Recombinant Live-Attenuated Respiratory Syncytial Virus Vaccine in RSV-Seronegative Infants 6 to 24 Months of Age
NCT02794870 ·Status: COMPLETED ·Phase: PHASE1
-
A Study to Learn About the Effects of Multiple Doses of Sisunatovir on People With Respiratory Syncytial Virus (RSV) Infection
NCT03258502 ·Status: COMPLETED ·Phase: PHASE2
-
A Phase I Randomized, Observer-Blinded, Dose-Ranging Study in Healthy Subjects 24 to <72 Months of Age
NCT02296463 ·Status: COMPLETED ·Phase: PHASE1