Trials / Completed
CompletedNCT02202356
A Study of ALS-008176 in Infants Hospitalized With RSV
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 183 (actual)
- Sponsor
- Alios Biopharma Inc. · Industry
- Sex
- All
- Age
- 12 Months
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ALS-008176 | |
| DRUG | Placebo |
Timeline
- Start date
- 2014-07-23
- Primary completion
- 2018-02-15
- Completion
- 2018-02-15
- First posted
- 2014-07-29
- Last updated
- 2025-02-03
Locations
77 sites across 14 countries: United States, Australia, Canada, Chile, Colombia, France, Japan, New Zealand, Panama, Romania, South Africa, Taiwan, Thailand, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02202356. Inclusion in this directory is not an endorsement.