Randomized, double-blind, placebo-controlled, dose-escalation Phase I safety study of inhaled N-IP-00001, to determine tolerability and safety in healthy volunteers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
8
Multiple ascending dose (MAD) study. Over the 2 dosing days participants will receive a total of 6 inhaled doses of 5 ml of N-IP-00001 at increasing concentrations, ranging from 0.5mg/ml to 16mg/ml (total volume loaded in the nebuliser is 6 ml per dose).
Nebulized treatment consisting of 0.9% saline solution.
Linear Clinical Research Ltd
Perth, Western Australia, Australia
Linear Clinical Research Ltd
Perth, Western Australia, Australia
Incidence of adverse events (AEs) and serious adverse events (SAEs)
Time frame: Up to 2 weeks
FEV1 measured by spirometry
Time frame: Up to 2 weeks
Changes in vital signs
Changes in blood pressure, temperature, pulseoximetry, and heart rate.
Time frame: Up to 2 weeks
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