This study is a randomized, double-blind, placebo-controlled, single-dose and multiple-dose, dose-escalation phase I clinical trial, aiming to evaluate the safety, tolerability, pharmacokinetic and pharmacodynamic characteristics, and immunogenicity of MWN105 injection in healthy Chinese volunteers, and to provide a reference for the next clinical trial. This study includes a single ascending dose (SAD) study and a multiple ascending dose (MAD) study. The SAD study consists of 4 dose groups; the MAD study consists of 2 dose groups and adopts a 4-week dose titration scheme. The study plans to enroll 55 volunteers. The primary endpoint is the incidence of adverse events. The secondary endpoints are the pharmacokinetic and pharmacodynamic characteristics and immunogenicity endpoints.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
55
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: From Day 1 to Day 50
Maximum Concentration (Cmax)
Cmax of MWN105.
Time frame: From Day 1 to Day 29
Time to Reach Maximum Concentration (Tmax)
Tmax of MWN105.
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 MWN105.
Time frame: From Day 1 to Day 29
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
AUC0-inf of MWN105.
Time frame: From Day 1 to Day 29
Elimination Half-Life (t1/2)
t1/2 of MWN105.
Time frame: From Day 1 to Day 29
Steady State Maximum Concentration (Cmax,ss)
Cmax,ss of MWN105.
Time frame: From Day 1 to Day 50
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Tmax,ss of MWN105.
Time frame: From Day 1 to Day 50
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
AUC0-t,ss of MWN105.
Time frame: From Day 1 to Day 50
Steady State Area Under the Curve from time zero to infinity (AUC0-inf,ss)
AUC0-inf,ss of MWN105.
Time frame: From Day 1 to Day 50
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
t1/2,ss of MWN105.
Time frame: rom Day 1 to Day 50
Change from baseline in body weight over time
Time frame: Baseline, Day 29, Day 50
Change from baseline in body mass index (BMI) over time
Time frame: Baseline, Day 29, Day 50
Change from baseline in waist circumference over time
Time frame: Baseline, Day 29, Day 50
Change from baseline in hip circumference over time
Time frame: Baseline, Day 29, Day 50
Change from baseline in waist-to-hip ratio over time
Time frame: Baseline, Day 29, Day 50
Change from baseline in fasting blood glucose over time
Time frame: Baseline, Day 29, Day 50
Change from baseline in C-peptide over time
Time frame: Baseline, Day 29, Day 50
Detect anti-drug antibodies (ADA) and their titers
Time frame: Baseline, Day 29, Day 50
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