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A Study to Evaluate MWN109 Injection in Healthy Subjects | Clinical Trials | Clareo Health

RECRUITINGPHASE1

A Study to Evaluate MWN109 Injection in Healthy Subjects

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

NCT06859853•Shanghai Minwei Biotechnology Co., Ltd

View on ClinicalTrials.gov

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.

Detailed Description

A total of 72 healthy volunteers are expected to be enrolled into this study. Study consists of 2 parts- Part A- Single Ascending dose (SAD) and part B- Multiple ascending dose (MAD). The entire study duration per participant is estimated to be a maximum of 8 weeks for the single ascending dose (SAD) part and 12 weeks for the multiple ascending dose (MAD) part. The end of study is defined as the date of the last visit of the last participant in the study.

Eligibility

Age

18 - 50 years

Sex

ALL

Healthy Volunteers

Yes

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.

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).
+33 more criteria

Locations (1)

Veritus Research

Melbourne, Victoria, Australia

Key Dates

Start Date

March 17, 2025

Primary Completion Date

September 25, 2025

Completion Date

November 25, 2025

Last Updated

April 15, 2025

Enrollment

ESTIMATED participants

Conditions

Overweight or Obese

Interventions

Placebo

DRUG

Subcutaneous single and mutiple dose

DRUG

Contacts

Guitao Zhang

CONTACT

+86 13580782564 gt.zhang@minweibiotech.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 15, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study to Evaluate MWN109 Injection in Healthy Subjects

Inclusion Criteria

Exclusion Criteria

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