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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06859853




Registration number
NCT06859853
Ethics application status
Date submitted
28/02/2025
Date registered
5/03/2025

Titles & IDs
Public title
A Study to Evaluate MWN109 Injection in Healthy Subjects
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 Injection in Healthy Subjects
Secondary ID [1] 0 0
MWN109-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight or Obese 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 - Placebo
Treatment: Drugs - Subcutaneous single and mutiple dose

Placebo comparator: placebo - Placebo

Active comparator: MWN109 injection - * Participants in SAD cohorts will be randomized to receive MWN109 injection or placebo across 5 cohorts. Planned dosage per cohorts are A1:0.25mg, A2:0.75mg, A3:1.5mg, A4:3.0mg, A5:6.0mg.
* Participants in MAD cohorts will be randomized to receive MWN109 injection or placebo across 4 cohorts. The IP will be administered via SC injection once weekly (QW) for approximately 4 doses. Planned dosage per cohorts are: B1-1.5 mg/1.5 mg/1.5 mg/1.5 mg; B2-1.5 mg/3.0 mg/3.0 mg/3.0 mg; B3-1.5 mg/3.0 mg/4.5 mg/6.0 mg; B4-1.5 mg/3.0 mg/6.0 mg/9.0 mg.


Treatment: Drugs: Placebo
Sub cutaneous injection on the abdomen by a qualified member of study staff.

Treatment: Drugs: Subcutaneous single and mutiple dose
Sub cutaneous injection on the abdomen by a qualified member of study staff.
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
Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration
Primary outcome [2] 0 0
Number of participants with change in laboratory parameters following treatment administration
Timepoint [2] 0 0
Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration
Primary outcome [3] 0 0
Number of participants with change in Vital signs following treatment administration
Timepoint [3] 0 0
Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration
Primary outcome [4] 0 0
Incidence of anti-drug antibody (ADA) formation following treatment administration
Timepoint [4] 0 0
Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration
Secondary outcome [1] 0 0
PK parameters- Cmax: maximum observed concentration
Timepoint [1] 0 0
SAD- Up to Day 29; MAD- Up to Day 50 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 29; MAD- Up to Day 50 post first dose administration.
Secondary outcome [3] 0 0
PK parameters- t½: half-life
Timepoint [3] 0 0
SAD- Up to Day 29; MAD- Up to Day 50 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 29; MAD- Up to Day 50 post first dose administration.
Secondary outcome [5] 0 0
PK parameters- AUCo-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 29; MAD- Up to Day 50 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 29; MAD- Up to Day 50 post first dose administration.
Secondary outcome [7] 0 0
PK parameters- CL/F: apparent clearance
Timepoint [7] 0 0
SAD- Up to Day 29; MAD- Up to Day 50 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 29; MAD- Up to Day 50 post first dose administration.
Secondary outcome [9] 0 0
PK parameters- MRT: mean residence time
Timepoint [9] 0 0
SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.

Eligibility
Key inclusion criteria
1. Males or females, of any race, aged 18 to 50 years (inclusive) at Screening.
2. [Part A: SAD] BMI of 19.0 to 40.0 kg/m2 (inclusive). [Part B: MAD] BMI of 27.0 to 45.0 kg/m2 (inclusive) with a minimum body weight of 50.0 kg for females and 55.0 kg for males.
3. History of stable body weight for 3 months (defined as change < 5%).
4. Resting heart rate (supine) = 45 bpm and = 90 bpm with a single 12-lead ECG at Screening.
5. Females of childbearing potential and males will agree to use contraception as detailed further in the protocol.
6. Male participants must agree to refrain from sperm donation and females should refrain from ova donation from D-1 until 4 months after the last administration.
7. Able to comprehend and willing to sign an ICF and to abide by all study requirements and restrictions.
Minimum age
18 Years
Maximum age
50 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 investigator (or designee).
2. History of pheochromocytoma or has uncontrolled blood pressure, as defined as systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg.
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 regardless of gender , confirmed by repeat measurement.
2. QRS duration > 110 msec confirmed by repeat measurement.
3. PR interval > 220 msec confirmed by repeat measurement.
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 Type I or II or clinical evidence of diabetes (e.g., hemoglobin A1c = 6.5%, fasting blood glucose = 126 mg/dL [7.0 mmol/L]) at Screening, non-fasting 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:

1. Elevation in serum amylase or lipase (> 1.5 × upper limit of normal [ULN]).
2. Have serum AST or ALT > 2 × ULN or total bilirubin >1.5 × ULN.
3. Have serum TG = 5.65 mmol/L (500 mg/dL) at screening
4. Estimated glomerular filtration rate (eGFR) < 90 mL/min/1.73m2.
10. History of clinically significant abnormal gastric emptying (e.g., gastric outlet obstruction, gastroparesis), severe chronic gastrointestinal diseases (e.g., having active ulcer within 6 months prior to Screening, active gastritis or esophagitis, or uncontrolled gastroesophageal reflux disease, irritable bowel disease or severe inflammatory bowel disease).
11. 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 Investigator.
12. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), or human immunodeficiency virus (HIV-1 and HIV-2) antibodies and p24 antigen.
13. 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 (within 2 years of Screening).
14. Any suicidal ideation as identified by endorsement of (answered yes to) any of the items numbered 1-5 on the Columbia Suicide Severity Rating Scale (C-SSRS), if applicable.
15. History of alcoholism or drug/chemical abuse within 1 year prior to D-1.
16. Alcohol consumption of > 21 units per week for males and > 14 units per week for females, on average. One unit of alcohol equals ½ pint (285 mL) of beer or lager, 1 glass (125 mL) of wine, or 1/6 gill (25 mL) of spirits.
17. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) during the Screening period.
18. Daily use of more than 10 cigarettes/day (on average), or 2 cigars/day (on average), or equivalent use of any tobacco product within 6 weeks prior to Screening.
19. Females of pregnant or lactating, or those with a positive pregnancy test at Screening.
20. Intolerance to venipuncture for blood sampling or history of fainting at blood drawing or sight of blood, unless deemed acceptable by the Investigator (or designee).
21. History of severe Types I-IV hypersensitivity reactions, anaphylaxis, cytokine release syndrome, atopic individuals, or allergic reactions to multiple drugs. If the Investigator is considering enrolling a participant with drug allergies, agreement with the Medical Monitor should be sought.
22. History of or suspected allergy or hypersensitivity to the investigational product or its components
23. 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 Investigator (or designee).
24. 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 Investigator (or designee).
25. Use or intend to use any nonprescription medications/products including vitamins, minerals, and phytotherapeutic/herbal/plant-derived preparations within 7 days prior to D-1, unless deemed acceptable by the Investigator (or designee).
26. 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 Investigator), severe trauma, or major surgical operation within 4 weeks prior to Screening.
27. Have been vaccinated within 4 weeks prior to Screening or plan to have vaccination during the study.
28. Donation of blood or massive blood loss (> 450 mL) OR receipt of blood products within 12 weeks prior to Screening.
29. Participation in a clinical study involving administration of an investigational agent/device or vaccine (new chemical entity) or having received a biological product within 12 weeks prior to Screening.
30. Poor peripheral venous access.
31. 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.
32. 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 Investigator or Medical Monitor, may interfere with any aspect of study conduct or interpretation of results.
33. Any skin condition and/or tattoo that may interfere with the evaluation of safety at the injection site.
34. Are deemed unsuitable by the Investigator (or designee) 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
2/03/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
25/11/2025
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Veritus Research - Melbourne
Recruitment postcode(s) [1] 0 0
3153 - Melbourne

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
Guitao Zhang
Address 0 0
Shanghai Minwei Biotechnology
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Guitao Zhang
Address 0 0
Country 0 0
Phone 0 0
+86 13580782564
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/NCT06859853