This is a randomized, double-blind, placebo-controlled, single ascending dose Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of MWX203 Injection in healthy Chinese subjects. The study comprises six dose cohorts with a planned enrollment of 54 subjects. The primary endpoint is safety, assessed by adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. Secondary endpoints include plasma PK parameters, urinary PK parameters, and immunogenicity (anti-drug antibodies).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
54
administered subcutaneously (SC)
administered SC
administered SC.
administered SC.
administered SC.
administered SC.
administered SC.
Hangzhou First People's Hospital
Hangzhou, Zhejiang, China
Incidence of adverse events (AEs)
The incidence of adverse events (AEs) and serious adverse events (SAEs).
Time frame: Through study completion, for at least 85 days
Maximum Concentration (Cmax)
Cmax of MWX203.
Time frame: Up to 48 hours post-dose
Time to Reach Maximum Concentration (Tmax)
Tmax of MWX203.
Time frame: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
AUC0-t of MWX203.
Time frame: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWX203.
Time frame: Up to 48 hours post-dose
Elimination Half-Life (t1/2)
t1/2 of MWX203.
Time frame: Up to 48 hours post-dose
Terminal Elimination Rate Constant (λz)
λz of MWX203.
Time frame: Up to 48 hours post-dose
Apparent Oral Clearance (CL/F)
CL/F of MWX203.
Time frame: Up to 48 hours post-dose]
Apparent Volume of Distribution (Vd/F)
Vd/F of MWX203.
Time frame: Up to 48 hours post-dose
Mean Residence Time (MRT)
MRT of MWX203.
Time frame: Up to 48 hours post-dose
Cumulative Urinary Excretion (Ae)
Ae of MWX203.
Time frame: Up to 48 hours post-dose
Fraction of Dose Excreted in Urine (Fe)
Fe of MWX203.
Time frame: Up to 48 hours post-dose
Renal Clearance (CLr)
CLr of MWX203.
Time frame: Up to 48 hours post-dose
Anti-Drug Antibody (ADA)
ADA of MWX203.
Time frame: Up to Day 85
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