The primary objective of the study is to investigate the safety and tolerability of ALX-0171. The secondary objectives are to evaluate the clinical effect of ALX-0171 and to explore the pharmacodynamics (PD) and the systemic pharmacokinetics (PK) of ALX-0171.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
53
Safety and Tolerability as measured by the incidence of treatment emergent adverse events, clinical laboratory parameters and physical examination
Time frame: 1 day before first dose to 14 days after first dose
Clinical activity as measured by the evaluation of the clinical response of the subjects
Time frame: 1 day before first dose to 14 days after first dose
Exploratory Pharmacokinetics as measured by the concentration of ALX-0171 in serum
Time frame: Day 3
Exploratory Pharmacodynamics as measured by the concentration of viral load in respiratory secretions and exploratory biomarkers in serum
Time frame: 1 day before first dose to 14 days after first dose
Immunogenicity as measured by the concentration of anti-drug antibodies in serum
Time frame: 1 day before first dose to 14 days after first dose
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Investigator Site 4
Brisbane, Australia
Investigator Site 2
Randwick, Australia
Investigator Site 3
Tasmania, Australia
Investigator Site 1
Westmead, Australia
Investigator Site 1
Antwerp, Belgium
Investigator Site 6
Antwerp, Belgium
Investigator Site 4
Brussels, Belgium
Investigator Site 5
Brussels, Belgium
Investigator Site 2
Ghent, Belgium
Investigator Site 3
Leuven, Belgium
...and 49 more locations