drugset / Trial / NCT02979431
Dose Ranging Study of ALX-0171 in Infants Hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective is to evaluate the anti-viral effect and safety of different doses of inhaled ALX-0171 in subjects hospitalized for Respiratory Syncytial Virus Lower Respiratory Tract Infection (RSV LRTI). The secondary objective is to evaluate the clinical activity, pharmacokinetic (PK) properties, pharmacodynamic (PD) effect and immunogenicity of different doses of inhaled ALX-0171.
Timeline
- Start
- 2017-01-11
- Primary completion
- 2018-05-25
- Completion
- 2018-05-25
Outcome
Met primary endpoint
registry analysis (superiority test); Placebo vs ALX-0171 9.0mg/kg; p <0.001; Log Rank NCT02979431 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALX-0171 | Protein / enzyme biologic | 3 mg/kg | Inhaled |
| Subject | ALX-0171 | Protein / enzyme biologic | 6 mg/kg | Inhaled |
| Subject | ALX-0171 | Protein / enzyme biologic | 9 mg/kg | Inhaled |