Phase 1 Clinical Study of MWN109 Injection in Healthy Chinese Volunteers

A Randomized, Double-Blind, Placebo-Controlled Phase 1a Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Subcutaneous Dose Escalation of MWN109 Injection in Healthy Chinese Volunteers

This is a randomized, double-blind, placebo-controlled, single- and multiple- dose-escalating Phase 1a study. The objective is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and immunogenicity of MWN109 Injection in healthy Chinese volunteers and to provide data for subsequent clinical trials.

The study includes a single ascending dose (SAD) part with 4 dose cohorts and a multiple ascending dose (MAD) part with 3 dose cohorts, using a 3-week dose titration regimen.

Approximately 58 volunteers will be enrolled. The primary endpoint is safety, assessed by adverse events, serious adverse events, vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. The secondary endpoint is the pharmacokinetic characteristics.

Inclusion Criteria:

1. 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.
2. 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/m^2 (inclusive).
3. 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.

Exclusion Criteria:

1. History of severe drug allergy (especially known or suspected allergy to the excipients of MWN109 Injection) or severe atopic allergic diseases/history (asthma, urticaria, eczematous dermatitis, etc.) or severe allergic constitution (allergy to two or more foods or drugs) (by inquiry).
2. History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury or other high-risk factors that may lead to pancreatitis, or serum amylase > 1.5 × upper limit of normal (ULN) at screening (by inquiry and examination).
3. Family history or history of medullary thyroid C-cell tumor/carcinoma; history of thyroid dysfunction or abnormal thyroid hormone levels (by inquiry).
4. History or presence at screening of digestive system diseases that may increase the risk to volunteers, such as pancreatitis, abnormal gastric emptying (e.g., gastroparesis, pyloric stenosis, pyloric obstruction, etc.), or severe chronic gastrointestinal diseases (e.g., history of intestinal obstruction, active ulcer within 6 months) (by inquiry).
5. History of infectious diseases (which, in the investigator's assessment, may significantly affect the safety evaluation of volunteers) or severe trauma within 4 weeks before screening, or major surgery within 3 months before screening (by inquiry and examination).
6. Use of any prescription or over-the-counter drug (including chemical drugs, vitamins, herbal medicines, etc.) within 2 weeks before dosing (by inquiry and examination);
7. History of substance abuse (by inquiry).
8. Blood donation or massive blood loss (> 400 mL) or blood transfusion within 3 months before screening (by inquiry).