This study is a randomized, double-blind, placebo-controlled, single-dose, dose-escalation Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of MWN117 injection in healthy and obese Chinese participants. The study consists of two parts. Part A includes two dose cohorts enrolling healthy participants, and Part B includes four dose cohorts enrolling obese participants. A total of 48 participants will be enrolled. Within each dose cohort, participants will be randomly assigned to receive a single subcutaneous injection of MWN117 or matching placebo. The primary endpoint is safety, assessed by adverse events and related examinations. Secondary endpoints include plasma pharmacokinetic (PK) parameters and urine PK parameters.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
48
A1, A2; administered subcutaneously (SC)
B1, B2, B3, B4; 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: Up to Day 169
Area Under the Curve From Time 0 to the Last Measurable Time Point (AUC0-last)
AUC0-last of MWN117.
Time frame: Up to 48 hours post-dose
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN117.
Time frame: Up to 48 hours post-dose
Maximum Plasma Concentration (Cmax)
Cmax of MWN117.
Time frame: Up to 48 hours post-dose
Time to Reach Maximum Plasma Concentration (Tmax)
Tmax of MWN117.
Time frame: Up to 48 hours post-dose
Elimination Half-Life (t1/2)
t1/2 of MWN117.
Time frame: Up to 48 hours post-dose
Renal Clearance (CLr)
CLr of MWN117.
Time frame: Up to 48 hours post-dose
Cumulative Excretion Amount (Ae)
Ae of MWN117.
Time frame: Up to 48 hours post-dose
Cumulative Excretion Fraction (Fe)
Fe of MWN117.
Time frame: Up to 48 hours post-dose
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.