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ALX-0171 Phase I Pharmacokinetic Study in Healthy Male Volunteers

Ablynx, a Sanofi company · 2013
ClinicalTrials.gov · Datasets · License: Public Domain · 2013
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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).
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