Clinical Trial: A Study of AK0529 in Infants Hospitalized With RSV
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: A Phase 1b, Open-label, Multicenter, Single Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of AK0529 in Infants Hospitalized With Respirat
Brief Summary: This study will assess the safety, tolerability, pharmacokinetics (PK) and anti-viral effect of single dose of AK0529 in infants hospitalized with respiratory syncytial virus (RSV).
Detailed Summary: This is a open-label Phase 1b study to evaluate the safety, tolerability, pharmacodynamics and Pharmacokinetics of AK0529 in hospitalized RSV infected infants age from 1 to 24 months.
Sponsor: Ark Biosciences Inc.
Current Primary Outcome: Number of Adverse Events [ Time Frame: Baseline through 7 days post administration ]
Original Primary Outcome: Number of Adverse Events [ Time Frame: Baseline through 7 days post administrstion ]
Current Secondary Outcome:
- Pharmacokinetics parameters, including maximum and minimum of drug concentration [ Time Frame: Baseline through 3 days post administration ]
- Pharmacokinetics parameters, including time to maximum concentration and half-time [ Time Frame: Baseline through 3 days post administration ]
- Pharmacokinetics parameters, including area under concentration-time curves (AUC) [ Time Frame: Baseline through 3 days post administration ]
Original Secondary Outcome: Same as current
Information By: Ark Biosciences Inc.
Dates:
Date Received: May 27, 2015
Date Started: September 2015
Date Completion: December 2016
Last Updated: June 28, 2016
Last Verified: June 2016
