This is a randomized, double-blind, placebo-controlled, single- and multiple- dose-escalating Phase 1a study. The objective is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN109 Injection in healthy Chinese volunteers and to provide data for subsequent clinical trials. The study includes a single ascending dose (SAD) part with 4 dose cohorts and a multiple ascending dose (MAD) part with 3 dose cohorts, using a 3-week dose titration regimen. Approximately 58 volunteers will be enrolled. The primary endpoint is safety, assessed by adverse events, serious adverse events, vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. The secondary endpoint is the pharmacokinetic characteristics.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
S1, S2 S3, S4; administered subcutaneously (SC)
M1, M2, M3; administered SC
administered SC
The First Affiliated Hospital of Yunnan University of Chinese Medicine (Yunnan Provincial Hospital of Traditional Chinese Medicine)
Kunming, Yunnan, China
Incidence of adverse events (AEs)
The incidence of adverse events (AEs) and serious adverse events (SAEs).
Time frame: From Day 1 to Day 43
Maximum Concentration (Cmax)
Cmax of MWN109.
Time frame: From Day 1 to Day 29
Time to Reach Maximum Concentration (Tmax)
Tmax of MWN109.
Time frame: From Day 1 to Day 29
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWN109.
Time frame: From Day 1 to Day 29
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN109.
Time frame: From Day 1 to Day 29
Elimination Half-Life (t1/2)
t1/2 of MWN109.
Time frame: From Day 1 to Day 29
Steady State Maximum Concentration (Cmax,ss)
Cmax,ss of MWN109.
Time frame: From Day 1 to Day 43
Steady State Minimum Concentration (Cmin,ss)
Cmin,ss of MWN109.
Time frame: From Day 1 to Day 43
Steady State Concentration (Cav,ss)
Cav,ss of MWN109.
Time frame: From Day 1 to Day 43
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Tmax,ss of MWN109.
Time frame: From Day 1 to Day 43
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
t1/2,ss of MWN109.
Time frame: From Day 1 to Day 43
Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)
AUC0-τ,ss of MWN109.
Time frame: From Day 1 to Day 43
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
AUC0-t,ss of MWN109.
Time frame: From Day 1 to Day 43
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