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Trial registered on ANZCTR


Registration number
ACTRN12625000057482p
Ethics application status
Submitted, not yet approved
Date submitted
13/12/2024
Date registered
21/01/2025
Date last updated
21/01/2025
Date data sharing statement initially provided
21/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A phase 1 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] 313271 0
MWN109-101
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Type 2 Diabetes Mellitus 335982 0
Obesity 336031 0
Condition category
Condition code
Metabolic and Endocrine 332573 332573 0 0
Diabetes
Diet and Nutrition 332597 332597 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will consist of 2 parts: SAD part and MAD part.

1. Part A: SAD study in healthy participants- The SAD study is planned to enroll approximately 40 male or female participants who will be assigned into 5 sequential dosing cohorts. Each cohort will enroll 8 participants who will be randomized to receive MWN109 injection or placebo in a ratio of 3:1 (6 on MWN109 injection and 2 on placebo). Cohort A1 to A5 will receive the IP doses 0.25, 0.75, 1.5, 3.0, or 6.0 mg. On D1, after at least 10 hours (h) overnight fasting, participants will be dosed with MWN109 or placebo, via SC injection on the abdomen by a qualified member of study staff.

2. Part B: MAD study in healthy participants- In the MAD study, 4 planned dose cohorts (Cohorts B1, B2, B3, and B4) are designed. Approximately 32 male or female participants will be enrolled, with 8 participants per cohort who will be randomized to receive MWN109 injection or placebo in a ratio of 3:1. The IP will be administered via SC injection once weekly (QW) for approximately 4 doses. Cohort B1 to B4 will receive following dose once weekly from week 1 to week 4- 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.

Adherence to the intervention will be from direct observation with timing of meal consumption recorded by the clinical staff.
Intervention code [1] 330110 0
Treatment: Drugs
Comparator / control treatment
Placebo will be single dose prefilled syringe with Citric acid monohydrate (C6H8O7·H2O), dibasic sodium phosphate dihydrate (Na2HPO4·2H2O), propylene glycol, Sodium hydroxide, diluted hydrochloric acid, water for injection as excipients.
Control group
Placebo

Outcomes
Primary outcome [1] 340086 0
To evaluate the safety and tolerability of MWN109 injection after single or multiple SC doses administered to healthy participants.
- Incidence of TEAEs
- Changes in laboratory safety tests,
- Change in 12-lead Electrocardiogram (ECG) findings
- Change in the vital signs
- Chage in the physical examination parameters
- Incidence of Anit drug antibodies (ADA) formation
All measures will be assessed as composite outcome
Timepoint [1] 340086 0
- Adverse events monitored from screening to end of study (EOS-Day 29 for part A; Day 50 for part B) post first dose administration.
- Safety Lab Parameters-Assessed on D-1, Day 8 and Day 29 for SAD; On Day-1, D14, D28 and D50 for MAD cohorts
- Vital signs and ECG - For SAD On day 1 of IP administration, vital signs will be performed at pre-dose, and at 3hr, 6hr and 12 hours post-dose, once/day of confinement and once at each follow up visit; MAD- On the days of administration (D1, D8, D15, and D22), the measurement should be performed pre dose, and at 3, 6, and 12 hours post-dose once/day of confinement and once at each follow up visit
Secondary outcome [1] 442625 0
To characterize the plasma pharmacokinetics (PK) of MWN109 injection after single subcutaneous doses administered to healthy participants
Timepoint [1] 442625 0
Blood samples will be collected single time on Day 1, 2, 3, 4, 5, 6, 8, 15, 22 and 29 post first dose administration.
Secondary outcome [2] 442626 0
To characterize the plasma pharmacokinetics (PK) of MWN109 injection after multiple subcutaneous doses administered to healthy participants
Timepoint [2] 442626 0
Blood samples will be collected single time on Day 1, 2, 3, 4, 5, 6, 8, 9, 11, 12, 13, 15, 22, 23, 24, 25, 26, 27, 29, 36, 43 and 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) more than equal to 45 bpm and less than equal to 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 6 months after the last administration.
7. 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
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. History of pheochromocytoma or has uncontrolled blood pressure, as defined as systolic blood pressure more than equal to 160 mmHg or diastolic blood pressure more than equal to 100 mmHg.
2. History of insulinoma, or has an event of blood glucose < 2.8 mmol/L within 1 year prior to Screening, or with more than equal to 3 times of hypoglycemia symptoms within 3 months prior to Screening.
3. History of febrile illness within 7 days prior to the first dose of IP or participants with evidence of active infection.
4. History of or active cardiovascular disease including significant arrhythmias such as atrial flutter, atrial fibrillation; New York Heart Association Class 1 to 4 heart failure; mild, moderate or severe coronary artery disease (CAD) or if not previously diagnosed with CAD, history of angina or symptoms consistent with CAD or other cardiovascular disease; uncontrolled hyperlipidemia and or triglycerides more than equal to 500 mg/dL at Screening; previous myocardial infarction, stroke, coronary artery bypass graft surgery, or percutaneous coronary intervention; deep vein thrombosis/pulmonary embolism; valve disorders or defects; abdominal aortic aneurysm; or pulmonary hypertension
5. Any of the following:
a) QTcF > 450 msec for males, > 470 msec for females, confirmed by repeat measurement.
b) QRS duration > 110 msec confirmed by repeat measurement.
c) PR interval > 220 msec confirmed by repeat measurement.
d) Findings which would make QTc measurements difficult or QTc data uninterpretable.
e) 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 1 or 2 or clinical evidence of diabetes (e.g., hemoglobin A1c more than equal to 6.5%, fasting blood glucose more than equal to 126 mg/dL [7.0 mmol/L]) at Screening, non-fasting glucose more than equal to 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:
a) Elevation in serum amylase or lipase (> 1.5 × upper limit of normal [ULN]).
b) Have serum AST or ALT > 2 × ULN or total bilirubin >1.5 × ULN.
c) Estimated glomerular filtration rate (eGFR) < 75 mL/min/1.73 meter square.
10. History of gastroparesis, gastric or peptic ulcer, active gastritis or esophagitis, or uncontrolled gastroesophageal reflux disease, irritable bowel disease or severe inflammatory bowel disease
11. History of clinically significant abnormal gastric emptying (e.g., gastric outlet obstruction), severe chronic gastrointestinal diseases (e.g., having active ulcer within 6 months prior to Screening); 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. History of alcoholism or drug/chemical abuse within 1 year prior to D-1.
15. 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.
16. Positive alcohol breath test result or positive urine drug screen (confirmed by repeat) during the Screening period.
17. 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.
18. Females of pregnant or lactating, or those with a positive pregnancy test at Screening.
19. 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).
20. History of severe Types 1-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.
21. History of or suspected allergy or hypersensitivity to the IP or its components.
22. 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).
23. 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).
24. 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).
25. 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.
26. Have been vaccinated within 4 weeks prior to Screening or plan to have vaccination during the study.
27. Donation of blood or massive blood loss (> 450 mL) OR receipt of blood products within 12 weeks prior to Screening.
28. 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.
29. Poor peripheral venous access.
30. 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.
31. 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.
32. 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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Sequential cohorts
Phase
Phase 1
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/02/2025
Actual
Date of last participant enrolment
Anticipated
1/08/2025
Actual
Date of last data collection
Anticipated
26/09/2025
Actual
Sample size
Target
72
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 27377 0
Veritus Research - Bayswater
Recruitment postcode(s) [1] 43475 0
3153 - Bayswater

Funding & Sponsors
Funding source category [1] 317723 0
Commercial sector/Industry
Name [1] 317723 0
Shanghai Minwei Biotechnology Co., Ltd.
Country [1] 317723 0
China
Primary sponsor type
Commercial sector/Industry
Name
Shanghai Minwei Biotechnology Co., Ltd.
Address
Country
China
Secondary sponsor category [1] 320039 0
None
Name [1] 320039 0
Address [1] 320039 0
Country [1] 320039 0
Other collaborator category [1] 283317 0
Commercial sector/Industry
Name [1] 283317 0
Novotech(Australia) Pty Limited
Address [1] 283317 0
Country [1] 283317 0
Australia

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 316413 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 316413 0
Ethics committee country [1] 316413 0
Australia
Date submitted for ethics approval [1] 316413 0
04/12/2024
Approval date [1] 316413 0
Ethics approval number [1] 316413 0

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

Contacts
Principal investigator
Name 137810 0
Prof Stephan Hall
Address 137810 0
Veritus Research Building 21, 885 Mountain Hwy Bayswater VIC Australia 3153
Country 137810 0
Australia
Phone 137810 0
+61 0494 096 663
Fax 137810 0
Email 137810 0
stephenhall@veritusresearch.com
Contact person for public queries
Name 137811 0
Stephan Hall
Address 137811 0
Veritus Research Building 21, 885 Mountain Hwy Bayswater VIC Australia 3153
Country 137811 0
Australia
Phone 137811 0
+61 0494 096 663
Fax 137811 0
Email 137811 0
stephenhall@veritusresearch.com
Contact person for scientific queries
Name 137812 0
Guitao Zhang
Address 137812 0
Shanghai Minwei Biotechnology Co., Ltd., No.13, Lane 889, Ziping Road, Pudong New Area, Shanghai
Country 137812 0
China
Phone 137812 0
+86 13580782564
Fax 137812 0
Email 137812 0
gt.zhang@minweibiotech.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.