drugset / Trial / NCT01875926
ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers
Non-randomizedParallel-groupOpen-labelTreatment
Summary
The overall aims of the study are: * To provide additional information on the pharmacokinetics of ALX-0171 by measuring (i) local (bronchoalveolar lavage fluid (BALF)) and systemic (plasma) concentrations of ALX-0171 after oral inhalation, and (ii) systemic (plasma) and urine concentrations after intravenous administration. * To further determine the safety and local and systemic tolerability of ALX-0171. * To further evaluate local (induced sputum) and/or systemic (serum) immunogenicity of ALX-0171, by analysing the potential occurrence of anti-drug antibodies (ADA).
Timeline
- Start
- 2013-05
- Primary completion
- 2013-10
- Completion
- 2013-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ALX-0171 | Protein / enzyme biologic | 0.3 mg/kg | Inhaled |
| Subject | ALX-0171 | Protein / enzyme biologic | 200 mg | Inhaled |