The primary objective of the study is to evaluate the antiviral effect and safety of inhaled ALX-0171 in adults diagnosed with respiratory syncytial virus (RSV) respiratory tract infection after hematopoietic stem cell transplantation (HSCT). The secondary objective is to assess the clinical activity, pharmacokinetics (PK), virology, and immunogenicity of inhaled ALX 0171 in adults diagnosed with RSV respiratory tract infection after HSCT.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Oral inhalation of ALX-0171 Dose 1 once daily for a maximum of 14 days
Oral inhalation of ALX-0171 Dose 2 once daily for a maximum of 14 days
Oral inhalation of Placebo once daily for a maximum of 14 days
Investigator site
Darlinghurst, Australia
Investigator site
Westmead, Australia
Investigator site
Leuven, Belgium
Investigator site 1
Valencia, Spain
Investigator site 2
Valencia, Spain
Time-weighted average change from baseline in log10 RSV nasal viral load
Time frame: From Day 1 to Day 7
Safety as measured by the incidence of treatment-emergent (serious) adverse events
Time frame: From Screening to Day 42
Nasal RSV load parameter: time to undetectable shedding
Time frame: From Day 1 to Day 42
Clinical stabilization (defined as respiratory rate <25/minute and stable oxygen saturation >92% on room air for at least 12 hours)
Time frame: From Day 1 to Day 42
Number of days without oxygen or with oxygen supplementation
Time frame: From Day 1 to Day 42
Progression to lower respiratory tract (LRT) disease in subjects presenting with upper respiratory tract infection (URTI) at baseline
Time frame: From Day 1 to Day 42
Concentration of ALX-0171 in serum
Measurement of ALX-0171 serum concentration at different time points from baseline until Day 14.
Time frame: Day 1 to Day 14
Immunogenicity as measured by the concentration of anti-ALX 0171 antibodies in serum
Time frame: From Day 1 to Day 42
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