Healthy Volunteers
Conditions
Brief summary
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.
Interventions
DRUGMWN109
S1, S2 S3, S4; administered subcutaneously (SC)
DRUGPlacebo
administered SC
Sponsors
Shanghai Minwei Biotechnology Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events (AEs) | From Day 1 to Day 43 | The incidence of adverse events (AEs) and serious adverse events (SAEs). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Steady State Concentration (Cav,ss) | From Day 1 to Day 43 | Cav,ss of MWN109. |
| Time to Reach Maximum Concentration at Steady State (Tmax,ss) | From Day 1 to Day 43 | Tmax,ss of MWN109. |
| Steady State Apparent Terminal Elimination Half-life (t1/2,ss) | From Day 1 to Day 43 | t1/2,ss of MWN109. |
| Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss) | From Day 1 to Day 43 | AUC0-τ,ss of MWN109. |
| Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss) | From Day 1 to Day 43 | AUC0-t,ss of MWN109. |
| Maximum Concentration (Cmax) | From Day 1 to Day 29 | Cmax of MWN109. |
| Time to Reach Maximum Concentration (Tmax) | From Day 1 to Day 29 | Tmax of MWN109. |
| Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t) | From Day 1 to Day 29 | AUC0-t of MWN109. |
| Area Under the Curve From Time 0 to Infinity (AUC0-inf) | From Day 1 to Day 29 | AUC0-inf of MWN109. |
| Elimination Half-Life (t1/2) | From Day 1 to Day 29 | t1/2 of MWN109. |
| Steady State Minimum Concentration (Cmin,ss) | From Day 1 to Day 43 | Cmin,ss of MWN109. |
| Steady State Maximum Concentration (Cmax,ss) | From Day 1 to Day 43 | Cmax,ss of MWN109. |
Countries
China
Outcome results
None listed