This is a Phase Ia, single-center, randomized, double-blind, placebo-controlled, single ascending dose (SAD) study. The primary purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of DBM-1152A Inhalation Solution in healthy Chinese adult subjects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Single dose via oral inhalation nebulization.
Single dose of blank vehicle via oral inhalation nebulization.
Xuzhou Central Hospital
Xuzhou, Jiangsu, China
Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) as a Measure of Safety and Tolerability
Safety and tolerability are evaluated through adverse events (AEs), vital signs, physical examination, laboratory tests (hematology, blood biochemistry, urinalysis, coagulation function), 12-lead ECG, Holter monitoring, and pupil examination.
Time frame: From informed consent up to Day 4 (End of study).
Peak Plasma Concentration (Cmax) of DBM-1152A
Maximum observed plasma concentration.
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time Zero to the Last Quantifiable Concentration (AUC0-t) of DBM-1152A
Area under the plasma concentration versus time curve from time 0 to the time of the last quantifiable concentration.
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC0-∞) of DBM-1152A
Area under the plasma concentration versus time curve from time 0 extrapolated to infinity.
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Time to Reach Peak Plasma Concentration (Tmax) of DBM-1152A
Time to reach maximum observed plasma concentration.
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Apparent Terminal Elimination Half-Life (t1/2) of DBM-1152A
Apparent terminal elimination half-life.
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
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Apparent Total Plasma Clearance (CL/F) of DBM-1152A
Apparent total plasma clearance calculated as dose divided by AUC0-∞.
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Apparent Volume of Distribution (Vz/F) of DBM-1152A
Apparent volume of distribution during the terminal phase.
Time frame: Pre-dose (within 1 hour before dosing) up to 72 hours post-dose.
Cumulative Amount of DBM-1152A Excreted Unchanged in Urine (Ae) (6 mg Cohort Only)
Cumulative amount of unchanged drug excreted in the urine.
Time frame: Pre-dose (within 24 hours before dosing) up to 72 hours post-dose.