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
Lead sponsor
Asset
MWN109
Subcutaneous · GLP-1 / GIP / glucagon triple
Listed sites
1
Recruiting sites
-
Actual enrollment
48
Study population
Healthy volunteers
Eligibility highlights
•BMI 19-28
Primary endpoint
•Adverse events (AEs)
Registered trial locations
Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Who this study enrolls
Who can enroll
Inclusion criteria
1. Male or female participants aged 18 to 45 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 19.0 to 28.0 kg/m^2 (inclusive).
3. From the time of signing the informed consent form (ICF) until 3 months after the last dose, participants must have no plans to become pregnant or to father a child, must agree to use effective contraceptive measures to prevent pregnancy or causing a partner to become pregnant, and must have no plans to donate sperm or eggs.
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).
Endpoints (13)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Safety / tolerability / PK
11 endpointsIncidence of adverse events (AEs)
Time frame:From Day 1 to Day 43
event count, event
Maximum Concentration (Cmax)
Time frame:From Day 1 to Day 29
concentration, descriptive
Time to Reach Maximum Concentration (Tmax)
Time frame:From Day 1 to Day 29
time to event, event
Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)
Time frame:From Day 1 to Day 29
descriptive
Area Under the Curve From Time 0 to Infinity (AUC0-inf)
Time frame:From Day 1 to Day 29
descriptive
Elimination Half-Life (t1/2)
Time frame:From Day 1 to Day 29
concentration, descriptive
Steady State Maximum Concentration (Cmax,ss)
Time frame:From Day 1 to Day 43
concentration, descriptive
Time to Reach Maximum Concentration at Steady State (Tmax,ss)
Time frame:From Day 1 to Day 43
time to event, event
Steady State Apparent Terminal Elimination Half-life (t1/2,ss)
Time frame:From Day 1 to Day 43
concentration, descriptive
Area Under Concentration-time Profiles during a Dose Interval (AUC0-τ,ss)
Time frame:From Day 1 to Day 43
concentration, descriptive
Steady State Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t,ss)
Time frame:From Day 1 to Day 43
descriptive
Other (unclassified)
2 endpointsSteady State Minimum Concentration (Cmin,ss)
Time frame:From Day 1 to Day 43
concentration, descriptive
Steady State Concentration (Cav,ss)
Time frame:From Day 1 to Day 43
concentration, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.