This study is a multicenter, randomized, double-blind, placebo-controlled, single and multiple ascending-dose phase 1 clinical trial aimed at evaluating the safety, tolerability, PK, PD, and immunogenicity of MWN110 Injection in healthy participants and overweight or obese participants. The study consists of two parts: Part 1, a single ascending dose (SAD) study in healthy participants with 8 dose cohorts; and Part 2, a multiple ascending dose (MAD) study in overweight or obese participants with 3 dose cohorts, with a dosing frequency of once weekly or once every 4 weeks. Approximately 103 participants will be enrolled. The primary endpoint is safety and tolerability, assessed by adverse events, vital signs, physical examination, laboratory tests, 12-lead electrocardiogram, and ophthalmic examination. Secondary endpoints include single-dose and multiple-dose PK parameters, PD parameters (body weight, BMI, waist circumference, muscle mass, body fat percentage, visceral fat, subcutaneous fat, bone mineral density), and immunogenicity (anti-drug antibodies).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
103
S1, S2, S3, S4, S5, S6, S7, S8; administered subcutaneously (SC)
M1, M2; administered SC
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
The incidence, severity, and relationship of treatment-emergent adverse events (TEAEs) to the investigational product
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From Day 1 to Day 169
Number of participants with abnormal vital signs
Time frame: From Day 1 to Day 169
Number of participants with abnormal ECG readings
Time frame: From Day 1 to Day 169
Number of participants with abnormal physical examination findings
Time frame: From Day 1 to Day 169
Number of participants with abnormal clinical laboratory measurements
Time frame: From Day 1 to Day 169
Number of participants with abnormal ophthalmological examination findings
Time frame: From Day 1 to Day 169
Maximum Concentration (Cmax)
Cmax of MWN110
Time frame: From Day 1 to Day 57
Time to Reach Maximum Concentration (Tmax)
Tmax of MWN110
Time frame: From Day 1 to Day 57
Under the Concentration Versus Time Curve (AUC)
Area AUC of MWN110
Time frame: From Day 1 to Day 57
Apparent Terminal Elimination Half-life (t1/2)
t1/2 of MWN110
Time frame: From Day 1 to Day 57
Steady State Maximum Concentration (Cmax,ss)
Cmax,ss of MWN110
Time frame: From Day 1 to Day 169
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Tmax,ss of MWN110
Time frame: From Day 1 to Day 169
Steady State Area Under the Concentration Versus Time Curve (AUCss)
AUCss of MWN110
Time frame: From Day 1 to Day 169
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
t1/2,ss of MWN110
Time frame: From Day 1 to Day 169
Change from Baseline in Body Weight
Change from baseline in body weight is calculated by subtracting the baseline weight measurement from the post-treatment weight measurement at a specified time point.
Time frame: From Day 1 to Day 169
Change from Baseline in Body Mass Index (BMI)
Change from baseline in BMI is calculated by subtracting the baseline BMI value from the post-treatment BMI value at a specified time point.
Time frame: From Day 1 to Day 169
Change from Baseline in Waist Circumference
Change from baseline in waist circumference is calculated by subtracting the baseline waist measurement from the post-treatment waist measurement at a specified time point.
Time frame: From Day 1 to Day 169
Change from Baseline in Muscle Mass
Change from baseline in muscle mass is calculated by subtracting the baseline muscle mass measurement from the post-treatment muscle mass measurement at a specified time point.
Time frame: From Day 1 to Day 169
Change from Baseline in Body Fat Percentage (BFP)
Change from baseline in BFP is calculated by subtracting the baseline BMI value from the post-treatment BFPvalue at a specified time point.
Time frame: From Day 1 to Day 169
Incidence and Titers of Anti-drug Antibody (ADA)
Time frame: From Day 1 to Day 169
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.