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A Study of ALS-008176 in Infants Hospitalized With RSV

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ClinicalTrials.gov Identifier: NCT02202356
Recruitment Status : Completed
First Posted : July 29, 2014
Last Update Posted : April 26, 2018
Sponsor:
Information provided by (Responsible Party):
Alios Biopharma Inc.

Brief 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)

Condition or disease Intervention/treatment Phase
Respiratory Syncytial Virus Infections Drug: ALS-008176 Drug: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled, 2-Part Study of Orally Administered ALS-008176 to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single Ascending Dosing and Multiple Ascending Dosing in Infants Hospitalized With Respiratory Syncytial Virus (RSV) Infection
Actual Study Start Date : July 23, 2014
Actual Primary Completion Date : February 15, 2018
Actual Study Completion Date : February 15, 2018

Arm Intervention/treatment
Experimental: ALS-008176 Single Dose
Single dose of ALS-008176 administered orally as a suspension
Drug: ALS-008176
Placebo Comparator: Placebo Single Dose
Single dose of placebo administered orally as a suspension
Drug: Placebo
Experimental: ALS-008176 Multiple Doses
Multiple doses of ALS-008176 administered orally as a suspension
Drug: ALS-008176
Placebo Comparator: Placebo Multiple Doses
Multiple doses of placebo administered orally as a suspension
Drug: Placebo



Primary Outcome Measures :
  1. Adverse Events [ Time Frame: Baseline through 6 days post-dose ]
  2. Physical Examinations [ Time Frame: Baseline through 6 days post-dose ]
  3. Vital Signs [ Time Frame: Baseline through 6 days post-dose ]
  4. 12-Lead ECGs [ Time Frame: Baseline through 6 days post-dose ]
  5. Clinical Laboratory Results [ Time Frame: Baseline through 6 days post-dose ]

Secondary Outcome Measures :
  1. RSV viral RNA concentrations in nasal aspirates [ Time Frame: Baseline through 6 days post-dose ]
  2. Emergence of resistance [ Time Frame: Baseline through 6 days post-dose ]
    Changes in RSV polymerase that result in reduced sensitivity to study drug

  3. Pharmacokinetic parameters, including maximum and minimum drug concentrations [ Time Frame: Baseline through 6 days post-dose ]
  4. Pharmacokinetic parameters, including time to maximum concentration and half-life [ Time Frame: Baseline through 6 days post-dose ]
  5. Pharmacokinetic parameters, including area under concentration-time curves (AUCs) [ Time Frame: Baseline through 6 days post-dose ]
  6. Pharmacokinetic parameters, including apparent oral clearance (CL/F) and apparent volume of distribution at steady state (VDss/F) [ Time Frame: Baseline through 6 days post-dose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female infant who is ≥1.0 to ≤12.0 months of age (inclusive), defined at the time of hospital admission, or <28 days of age (neonate cohort only). Note: all subjects, including neonates, must have been discharged from the hospital after birth and are now being admitted due to an RSV related illness

Exclusion Criteria:

  • Prematurity
  • Receiving invasive endotracheal mechanical ventilation
  • Poorly functioning gastrointestinal tract
  • Anticipated to be discharged from the hospital in <24 hours from the time of randomization
  • Prior exposure to palivizumab

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02202356


  Show 77 Study Locations
Sponsors and Collaborators
Alios Biopharma Inc.
Investigators
Study Director: Matthew McClure, M.D. Alios BioPharma

Responsible Party: Alios Biopharma Inc.
ClinicalTrials.gov Identifier: NCT02202356     History of Changes
Other Study ID Numbers: ALS-8176-503
2013-005104-33 ( EudraCT Number )
First Posted: July 29, 2014    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes

Keywords provided by Alios Biopharma Inc.:
RSV
Respiratory Syncytial Virus

Additional relevant MeSH terms:
Infection
Virus Diseases
Respiratory Syncytial Virus Infections
Pneumovirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections