Trials / Terminated
TerminatedNCT02460016
A Study of AK0529 in Infants Hospitalized With RSV
A Phase 1b, Open-label, Multicenter, Single Dose Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of AK0529 in Infants Hospitalized With Respiratory Syncytial Virus Infection
- Status
- Terminated
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 1 (actual)
- Sponsor
- Shanghai Ark Biopharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 1 Month – 24 Months
- Healthy volunteers
- Not accepted
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 description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AK0529 | AK0529 pellets for oral administration |
Timeline
- Start date
- 2015-08-28
- Primary completion
- 2015-11-03
- Completion
- 2015-11-03
- First posted
- 2015-06-02
- Last updated
- 2018-07-02
Locations
1 site across 1 country: Australia
Source: ClinicalTrials.gov record NCT02460016. Inclusion in this directory is not an endorsement.