A Study to Evaluate MWN109 Injection in Healthy Subjects

NCT06859853 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: MWN109-101
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a Phase1, randomized, double-blinded, and placebo-controlled study. In each cohort, enrolled participants will be randomized to receive either placebo or MWN109.

Conditions

Overweight or Obese

Outcome Measures

Primary Outcomes (4)

• Number of participants with Incidence of treatment emergent adverse events (TEAEs) following treatment administration

  Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration

• Number of participants with change in laboratory parameters following treatment administration

  Changes in clinical laboratory parameters include urine drug screening, alcohol breath test. serum virology, pregnancy test. hematology, blood chemistry, urinalysis, coagulation function, and thyroid function.

  Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration

• Number of participants with change in Vital signs following treatment administration

  Vital signs include measurement of heart rate (HR) respiration rate (RR), systolic and diastolic blood pressure (BP) and body temperature.

  Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration

• Incidence of anti-drug antibody (ADA) formation following treatment administration

  Part A- Up to Day 29; Part B- Up to Day 50 post first dose administration

Secondary Outcomes (9)

• PK parameters- Cmax: maximum observed concentration

  SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.

• PK parameters- -Tmax: time to reach maximum concentration

  SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.

• PK parameters- t½: half-life

  SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.

• PK parameters- AUC0-inf: area under the concentration-time curve from time zero to the theoretical infinite time

  SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.

• PK parameters- AUCo-t: area under the concentration-time curve from time zero to the time of the last quantifiable concentration

  SAD- Up to Day 29; MAD- Up to Day 50 post first dose administration.

Study Arms (2)

placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo; Drug: Subcutaneous single and mutiple dose

MWN109 injection

ACTIVE COMPARATOR

* 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.

Drug: Placebo; Drug: Subcutaneous single and mutiple dose

Interventions

Placebo DRUG

Sub cutaneous injection on the abdomen by a qualified member of study staff.

MWN109 injection; placebo

Subcutaneous single and mutiple dose DRUG

Sub cutaneous injection on the abdomen by a qualified member of study staff.

MWN109 injection; placebo

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males or females, of any race, aged 18 to 50 years (inclusive) at Screening.
• \[Part A: SAD\] 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.
• History of stable body weight for 3 months (defined as change \< 5%).
• Resting heart rate (supine) ≥ 45 bpm and ≤ 90 bpm with a single 12-lead ECG at Screening.
• Females of childbearing potential and males will agree to use contraception as detailed further in the protocol.
• 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.
• Able to comprehend and willing to sign an ICF and to abide by all study requirements and restrictions.

You may not qualify if:

• 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).
• History of pheochromocytoma or has uncontrolled blood pressure, as defined as systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg.
• 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.
• History of febrile illness within 7 days prior to the first dose of IP or participants with evidence of active infection.
• Any of the following:
• QTcF \> 450 msec regardless of gender , confirmed by repeat measurement.
• QRS duration \> 110 msec confirmed by repeat measurement.
• PR interval \> 220 msec confirmed by repeat measurement.
• Findings which would make QTc measurements difficult or QTc data uninterpretable.
• History of additional risk factors for torsades de pointes (e.g., heart failure, hypokalemia, family history of long QT syndrome).
• Known history or family history of thyroid C-cell tumor/carcinoma, multiple endocrine neoplasia syndrome type 2 (MEN2), thyroid dysfunction or thyroid hormone abnormality.
• 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
• History of acute or chronic pancreatitis, symptomatic gallbladder disease, pancreatic injury and other high-risk factors that may lead to pancreatitis.
• With any of following laboratory abnormality:
• Elevation in serum amylase or lipase (\> 1.5 × upper limit of normal \[ULN\]).

Sponsors & Collaborators

• Shanghai Minwei Biotechnology Co., Ltd: lead

Study Sites (1)

Veritus Research

Melbourne, Victoria, 3153, Australia

RECRUITING

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Guitao Zhang

  Shanghai Minwei Biotechnology

  STUDY CHAIR

Central Study Contacts

Guitao Zhang

CONTACT

+86 13580782564; gt.zhang@minweibiotech.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2025
• First Posted: March 5, 2025
• Study Start: March 17, 2025
• Primary Completion: September 25, 2025
• Study Completion: November 25, 2025
• Last Updated: April 15, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)