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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06938269




Registration number
NCT06938269
Ethics application status
Date submitted
14/04/2025
Date registered
22/04/2025

Titles & IDs
Public title
A Phase I Study to Evaluate MWN109 Tablets in Healthy Adult Participants
Scientific title
A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWN109 Tablets in Healthy Adult Participants
Secondary ID [1] 0 0
MWN109-T-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight or Obesity 0 0
Condition category
Condition code
Diet and Nutrition 0 0 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - MWN109 tablet
Treatment: Drugs - Placebo

Placebo comparator: Placebo - Participants in SAD cohorts will be randomized to receive a single dose of MWN109 tablet or placebo across 4 cohorts. Participants in MAD cohorts will be randomized to receive MWN109 tablet or placebo once daily for 28 days across 3 cohorts.

Active comparator: MWN109 tablets - Participants in SAD cohorts will be randomized to receive a single dose of MWN109 tablet or placebo across 4 cohorts. Planned dosage per cohorts are A1:7.5mg, A2:15mg, A3:30mg, A4:45mg.

Participants in MAD cohorts will be randomized to receive MWN109 tablet or placebo once daily for a total of 28 days across 3 cohorts. Initiation and dose levels of MAD cohorts will be determined in the safety review and dose escalation meeting by the Safety Review Committee based on the review of safety, tolerability, and PK data from SAD part. The target doses could be 15mg, 30mg and 45 mg.


Treatment: Drugs: MWN109 tablet
Strength: 7.5mg, 15mg, 30mg, and 45 mg; Administration: Oral.

Treatment: Drugs: Placebo
Administration: Oral.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Incidence of treatment emergent adverse events (TEAEs) following treatment administration
Timepoint [1] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Primary outcome [2] 0 0
Number of participants with change in laboratory parameters following treatment administration
Timepoint [2] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Primary outcome [3] 0 0
Number of participants with change in 12-lead ECG following treatment administration
Timepoint [3] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Primary outcome [4] 0 0
Number of participants with change in Vital signs following treatment administration
Timepoint [4] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Primary outcome [5] 0 0
Incidence of anti-drug antibody (ADA) formation following treatment administration
Timepoint [5] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Primary outcome [6] 0 0
Number of participants with change in physical examinations following treatment administration
Timepoint [6] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Secondary outcome [1] 0 0
PK parameters- Cmax: maximum observed concentration
Timepoint [1] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Secondary outcome [2] 0 0
PK parameters- Tmax: time to reach maximum concentration
Timepoint [2] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Secondary outcome [3] 0 0
PK parameters- t1/2: half-life
Timepoint [3] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Secondary outcome [4] 0 0
PK parameters- AUC0-inf: area under the concentration-time curve from time zero to the theoretical infinite time
Timepoint [4] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Secondary outcome [5] 0 0
PK parameters- AUC0-t: area under the concentration-time curve from time zero to the time of the last quantifiable concentration
Timepoint [5] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Secondary outcome [6] 0 0
PK parameters- AUC0-168h: area under the concentration-time curve from time zero to 168 h post dose
Timepoint [6] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Secondary outcome [7] 0 0
PK parameters- CL/F: apparent clearance
Timepoint [7] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Secondary outcome [8] 0 0
PK parameters- Vd/F: apparent volume of distribution
Timepoint [8] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Secondary outcome [9] 0 0
PK parameters- MRT: mean residence time
Timepoint [9] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration
Secondary outcome [10] 0 0
PK parameters- terminal elimination rate constant
Timepoint [10] 0 0
SAD: Up to Day 22; MAD: Up to Day 56 post first dose administration

Eligibility
Key inclusion criteria
1. Males or females aged 18 to 60 years (inclusive) at the time of signing the informed consent.
2. [Part A: SAD] Body mass index (BMI) of 19.0 to 40.0 kg/m2 (inclusive) with body weight > 65.0 kg and <130.0 kg. [Part B: MAD] BMI of 27.0 to 45.0 kg/m2 (inclusive) with body weight > 65.0 kg and <130.0 kg.
3. Stable body weight within 3 months before screening (defined as self-reported change < 5%).
4. Resting heart rate (supine) = 45 bpm and = 90 bpm with a single 12-lead ECG at Screening. If the heart rate is > 90 or < 45 bpm, it is to be repeated 2 more times (separated by at least 2 min) and the average of the 3 heart rate values is to be used to determine the participant's eligibility.
5. Females of childbearing potential and males who are not surgically sterile (>180 days since vasectomy with no viable sperm) will agree to use contraception from Screening until 4 months after the last administration, OR females of non-reproductive potential as defined below:

* Postmenopausal as defined as:

* No menses for at least 12 months; OR
* No menses for at least 12 months AND with a follicle-stimulating hormone level > 40 IU/L or according to the definition of "postmenopausal range" for the laboratory involved; OR
* History of hysterectomy; OR
* History of bilateral oophorectomy
6. Male participants must agree to refrain from sperm donation and females should refrain from ova donation from Screening until 4 months after the last administration.
7. Willing to maintain current general diet and physical activity regimen, except for the physical activity in the 72 h before each blood sample collection for the clinical laboratory analysis, which should not be strenuous, and willing to be restrained from alcohol and smoking during the study period.
8. Able to comprehend and willing to sign an informed consent form (ICF) and to abide by all study requirements and restrictions.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Significant history or clinical manifestation of any cardiovascular, metabolic, allergic, endocrine, renal, hepatic, gastrointestinal, hematological, pulmonary, respiratory, dermatological, neurological, gynecological, psychiatric disorders, as determined by the Principal Investigator (or delegate).
2. Screening blood pressure in supine outside the ranges 90-159 mmHg systolic, 50-95 mmHg diastolic. If abnormal blood pressure is observed, the blood pressure is to be repeated 2 more times, and the average of the 3 blood pressure values is to be used to determine the participant eligibility.
3. History of insulinoma, or has an event of blood glucose < 2.8 mmol/L within 1 year prior to Screening, or with = 3 times of hypoglycemia symptoms within 3 months prior to Screening.
4. History of febrile illness within 7 days prior to the first dose of IP or participants with evidence of active infection.
5. Any of the following:

1. QTcF > 450 msec confirmed by repeat measurement;
2. QRS duration > 120 msec confirmed by repeat measurement;
3. PR interval > 220 msec confirmed by repeat measurement. Notes: Regarding a), b) and c), ECG is to be repeated 2 more times when out-of-range and the average of the values is to be used to determine the participant eligibility;
4. Findings which would make QTc measurements difficult or QTc data uninterpretable;
5. History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
6. Known history or family history of thyroid C-cell tumor/carcinoma, multiple endocrine neoplasia syndrome type 2 (MEN2), thyroid dysfunction or thyroid hormone abnormality.
7. History of diabetes mellitus or clinical evidence of diabetes (e.g., hemoglobin A1c = 6.5%, fasting plasma glucose = 126 mg/dL [7.0 mmol/L]) at Screening, non-fasting plasma glucose = 200 mg/dL (11.1 mmol/L) at Screening, or use of any hypoglycemic drugs during Screening or within 3 months prior to Screening.
8. History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury and other high-risk factors that may lead to pancreatitis.
9. With any of following laboratory abnormality at screening and confirmed by a single repeat at the discretion of the Principal Investigator (or delegate):

a) Elevation in serum amylase or lipase (> 1.5 × upper limit of normal [ULN]). b) Have serum aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 × ULN or total bilirubin >1.5 × ULN.

c) Have serum triglycerides (TG) = 5.65 mmol/L (500 mg/dL) at Screening. d) Estimated glomerular filtration rate (eGFR) < 80 mL/min/1.73m2 by Cockcroft-Gault equation as below: (140 - age) × mass (kg)/72 × creatinine (mg/dL); multiply by 0.85 if female.
10. Untreated or uncontrolled hypothyroidism/hyperthyroidism defined as thyroid-stimulating hormone > 6 mIU/L or < 0.4 mIU/L.
11. History of clinically significant (in the opinion of the Principal Investigator or delegate) abnormal gastric emptying (e.g., gastric outlet obstruction, gastroparesis), chronic gastrointestinal diseases (e.g., having active ulcer within 6 months prior to Screening, active gastritis or esophagitis, or gastroesophageal reflux disease, irritable bowel disease or severe inflammatory bowel disease).
12. Presence of clinically significant acute gastrointestinal symptoms (e.g., nausea, vomiting, heartburn or diarrhoea) or malabsorptive states (celiac disease, lactose intolerance or chronic pancreatitis), as judged by the Principal Investigator (or delegate).
13. Any history or plan of gastrointestinal surgery excluding appendectomy.
14. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or human immunodeficiency virus (HIV-1 and HIV-2) antibodies.
15. Any history of severe psychiatric disorder such as major depressive disorder, bipolar disorder, and schizophrenia, or history of suicidal ideation, behavior or attempts or other psychiatric disorder.
16. History of alcoholism or drug/chemical abuse within 1 year prior to D-1.
17. Alcohol consumption of > 21 units per week for males and > 14 units per week for females, on average. One unit of alcohol equals 1/2 pint (285 mL) of beer, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
18. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) during the Screening period.
19. Daily use of more than 10 cigarettes/day (on average), or 2 cigars/day (on average), or equivalent use of any nicotine-containing product within 6 weeks prior to Screening.
20. Participant is unwilling to refrain from strenuous exercise (e.g., heavy lifting, weight training, and aerobics) for 72 h prior to each blood collection for clinical laboratory tests.
21. Females of pregnant or lactating, or those with a positive pregnancy test at Screening.
22. Intolerance to venipuncture for blood sampling or history of fainting at blood drawing or sight of blood, unless deemed acceptable by the Principal Investigator (or delegate).
23. Long-term use of drugs directly affecting the gastrointestinal motility (including but not limited to mosapride, cisapride) or gastrointestinal surgery within 12 weeks prior to Screening and are inappropriate for participation in this clinical study as assessed by the Principal Investigator (or delegate).
24. History of severe Types I-IV hypersensitivity reactions, anaphylaxis, cytokine release syndrome, atopic individuals, or allergic reactions to multiple drugs. If the Principal Investigator (or delegate) is considering enrolling a participant with multiple drug allergies, agreement with the Medical Monitor should be sought.
25. History of or suspected allergy or hypersensitivity to the IP or its components.
26. Use or intend to use any prescription medications/products other than hormone replacement therapy, oral, implantable, transdermal, injectable, or intrauterine contraceptives within 14 days prior to dosing, unless deemed acceptable by the Principal Investigator (or delegate)and agreement with the Sponsor.
27. Use or intend to use slow-release medications/products considered to still be active within 14 days prior to D-1, unless deemed acceptable by the Principal Investigator (or delegate).
28. Use of any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to D-1 or during the study, unless deemed acceptable by the Principal Investigator (or delegate) and agreement with Sponsor, with the exception of paracetamol/acetaminophen (maximum 2 g per day for up to 3 days) and topically applied medications which is permitted up to 48 h prior to dosing.
29. Participants with a history of infectious diseases (which may affect the ability of the participant to participate in the study at the discretion of the Principal Investigator or delegate), severe trauma, or major surgical operation within 4 weeks prior to Screening.
30. Have been vaccinated within 4 weeks prior to Screening or plan to have vaccination during the study.
31. Donation of blood or massive blood loss (> 450 mL) OR receipt of blood products within 12 weeks prior to Screening, plasma from 2 weeks prior to Screening, and platelets from 6 weeks prior to Screening.
32. Participation in a clinical study involving administration of an investigational agent/device or vaccine (new chemical entity) within 30 days or 5 half-lives, or having received a biological product within 12 weeks prior to Screening.
33. Poor peripheral venous access.
34. Are investigative site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child, or sibling, whether biological or legally adopted.
35. The presence of clinically significant physical examination, vital sign, drug, or ECG findings at Screening or baseline or laboratory findings at Screening that, in the opinion of the Principal Investigator (or delegate) or Medical Monitor, may interfere with any aspect of study conduct or interpretation of results.
36. Are deemed unsuitable by the Principal Investigator (or delegate) for any other reason.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/06/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2026
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 0 0
CMAX Clinical Research - Adelaide
Recruitment postcode(s) [1] 0 0
5000 - Adelaide

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Shanghai Minwei Biotechnology Co., Ltd
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Yang Fu
Address 0 0
Country 0 0
Phone 0 0
86 13107731990
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

Data sharing statement


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06938269