Phase 1 study investigating safety of lanadelumab administration to patients with lung injury
This study will investigate the safety of inhibition of plasma kallikrein by lanadelumab administration in patients with lung injury.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
48
Monoclonal antibody that targets active plasma kallikrein
Saline control
St Vincent's Hospital Melbourne
Melbourne, Victoria, Australia
Number of Participants With Treatment-Related Adverse Events
Blood gases, pH, bicarbonate, carbon dioxide and lactic acid levels. If the participant is receiving mechanical ventilation, the ventilator settings will be constantly monitored. Chest X-ray, as indicated. Constant monitoring of haemodynamics (pulse rate, blood pressure) via an arterial cannula, use of vasoactive medications, and constant monitoring of ECG. Fluid balance, including urine output. Serum creatinine, electrolytes, liver function, creatinine kinase, FBE and coagulation will be measured daily or less frequently as decided by the treating team. If there is suspicion of infection, then appropriate samples will be taken for microbiological examination. Neurological function will be assessed several times per day.
Time frame: 28 days
Blood bradykinin concentration
Blood bradykinin concentration
Time frame: 0, 6, 12, and 24 hours
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