This is the first-in-human, single-center, randomized, double-blinded, placebocontrolled, single-dose and multiple-dose escalation Phase Ia study
Single ascending dose (SAD), healthy participants will be randomized to receive a single inhalational dose of either XW001 or placebo in each of the planned SAD cohorts. Multiple ascending dose (MAD), healthy participants will be randomized to receive inhalational doses of XW001 or placebo in each of the planned MAD cohorts.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
81
The Third Hospital of Changsha
Changsha, Hunan, China
Safety/tolerance endpoints
Number and percentage of treatment emergent adverse events (TEAE) and serious adverse events (SAE)
Time frame: 28 Days for Cohort A and 42 Days for Cohort B
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