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Clinical Trials in China / NCT07799025
Active, not recruiting Phase 1

Phase 1 Clinical Study of MWX203 Injection in Healthy Subjects

NCT07799025 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Minwei Biotechnology Co., Ltd
Phase
Phase 1
Started
2025-07-07
Last updated
2026-09-02

Condition(s) studied

Healthy Volunteers

Investigational drug(s) / intervention(s)

MWX203 S1PlaceboMWX203 S2MWX203 S3MWX203 S4MWX203 S5MWX203 S6

MWX203 S1: administered subcutaneously (SC)

Placebo: administered SC

MWX203 S2: administered SC.

MWX203 S3: administered SC.

MWX203 S4: administered SC.

MWX203 S5: administered SC.

MWX203 S6: administered SC.

Study summary

This is a randomized, double-blind, placebo-controlled, single ascending dose Phase 1 study designed to evaluate the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) profiles of MWX203 Injection in healthy Chinese subjects.

The study comprises six dose cohorts with a planned enrollment of 54 subjects. The primary endpoint is safety, assessed by adverse events (AEs), serious adverse events (SAEs), vital signs, physical examinations, laboratory tests, and 12-lead electrocardiograms. Secondary endpoints include plasma PK parameters, urinary PK parameters, and immunogenicity (anti-drug antibodies).

Eligibility

Sex
ALL
Min age
18 Years
Max age
55 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Healthy male and female subjects aged 18 to 55 years (inclusive) at the time of signing the informed consent form (ICF). 2. Fasting serum LDL-C ≥ 2.6 mmol/L (100 mg/dL) and \< 4.1 mmol/L (158 mg/dL), and fasting triglycerides ≥ 1.1 mmol/L (100 mg/dL) and \< 5.7 mmol/L (500 mg/dL) at screening; no lipid-regulating drugs used within the past 3 months. 3. Body mass index (BMI) from 19.0 to 30.0 kg/m², inclusive, at screening; male subjects must have a body weight ≥ 50.0 kg and female subjects must have a body weight ≥ 45.0 kg. 4. Stable diet and physical-activity habits for 4 weeks prior to screening; no major changes to diet or exercise are planned during the study, and participants will not follow any weight-loss plan. 5. Subjects or their partners have no plans for pregnancy, sperm donation, or egg donation from the time of signing the ICF until at least 6 months after dosing, and agree to use medically-recognized, effective non-pharmacological contraceptive methods throughout the study. 6. Voluntarily participate in the study; able to read, understand, and sign the ICF before study participation; willing to comply with the study protocol and expected to complete the study. Exclusion Criteria: 1. Any infectious disease within 4 weeks prior to screening (as judged by the investigator to affect the subject's ability to participate in the study). 2. Serious trauma or major surgery (requiring general anesthesia) within 6 months prior to screening, or planned major surgery during the study. 3. At screening, any of the following laboratory abnormalities: alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), or total bilirubin \> 1.5 × ULN; serum creatinine \> 1.2 × ULN; or estimated glomerular filtration rate (eGFR) \< 90 mL/min/1.73 m² (calculated using the CKD-EPI equation, Appendix 4). 4. QTcF ≥ 450 ms (male) or ≥ 470 ms (female) at screening; or clinically-significant abnormalities on the 12-lead electrocardiogram. 5. HbA1c \> ULN. 6. Overall atherosclerotic cardiovascular disease (ASCVD) risk assessed by the investigator as moderate or high risk at screening. 7. Use of any liver-targeted oligonucleotide drug within 1 year prior to screening. 8. Pregnant or lactating female subjects at screening. 9. Difficult venous access, difficult subcutaneous injection, or intolerance to repeated venipuncture; or clinically significant needle phobia or blood phobia history as judged by the investigator. 10. Use of any over-the-counter medications, prescription medications, traditional Chinese medicine, vitamins, or health supplements within 2 weeks prior to screening or within 5 half-lives of any prior medication (whichever is longer). 11. Receipt of any live vaccine, live attenuated vaccine, or vaccines containing live viral components within 3 months prior to screening or planned vaccination during the study. 12. Any other condition judged by the investigator to make the subject unsuitable for participation in this study.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Hangzhou First People's Hospital Hangzhou Zhejiang

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07799025 on ClinicalTrials.gov ↗ ← All trials in China