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).
Male or female participants aged 18 to 65 years (inclusive) at the time of signing the informed consent form (ICF); the proportion of either gender shall not be less than 1/3.
Male participants with body weight not less than 50 kg, female participants with body weight not less than 45 kg; body mass index (BMI) within 20.0 to 40.0 kg/m² (inclusive).
Female participants must have no plans for pregnancy or egg donation from 14 days before the first dose to 6 months after the last dose and must agree to use effective contraceptive measures to avoid pregnancy; male participants must have no plans for fathering a child or sperm donation from the first dose to 6 months after the last dose and must agree to use effective contraceptive measures to avoid causing partner pregnancy.
Known or suspected allergy to the investigational product or its excipients, or history of severe allergy (including any food or drug allergy).
Body weight change >5% within 3 months prior to screening (weight change % = [maximum weight in 3 months - minimum weight in 3 months] / maximum weight in 3 months x 100%).
Diagnosed with secondary overweight or obesity.
History of pancreatitis (chronic pancreatitis or idiopathic acute pancreatitis); serum amylase or lipase above the upper limit of normal.