Phase 1 Clinical Study of MWX203 Injection in Healthy Subjects

NCT07799025 | Active Not Recruiting Phase 1

• 1 other identifier: MWX203-I
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  The incidence of adverse events (AEs) and serious adverse events (SAEs).

  Through study completion, for at least 85 days

Secondary Outcomes (13)

• Maximum Concentration (Cmax)

  Up to 48 hours post-dose

• Time to Reach Maximum Concentration (Tmax)

  Up to 48 hours post-dose

• Area Under the Curve From Time 0 to Last Quantifiable Time Point (AUC0-t)

  Up to 48 hours post-dose

• Area Under the Curve From Time 0 to Infinity (AUC0-inf)

  Up to 48 hours post-dose

• Elimination Half-Life (t1/2)

  Up to 48 hours post-dose

Other Outcomes (4)

• Change From Baseline in Serum ANGPTL3

  Through study completion, for at least 85 days

• Change From Baseline in Serum PCSK9

  Up to Day 85

• Fasting Blood Lipid Parameters

  Through study completion, for at least 85 days

Study Arms (6)

MWX203 Cohort 1

EXPERIMENTAL

Escalating doses of MWX203 or matching placebo were administered via subcutaneous injection to healthy volunteers.

Drug: MWX203 S1; Drug: Placebo

MWX203 Cohort 2

EXPERIMENTAL

Escalating doses of MWX203 or matching placebo were administered via subcutaneous injection to healthy volunteers.

Drug: Placebo; Drug: MWX203 S2

MWX203 Cohort 3

EXPERIMENTAL

Escalating doses of MWX203 or Matching placebo were administered via subcutaneous injection to healthy volunteers.

Drug: Placebo; Drug: MWX203 S3

MWX203 Cohort 4

EXPERIMENTAL

Escalating doses of MWX203 or Matching placebo were administered via subcutaneous injection to healthy volunteers.

Drug: Placebo; Drug: MWX203 S4

MWX203 Cohort 5

EXPERIMENTAL

Escalating doses of MWX203 or Matching placebo were administered via subcutaneous injection to healthy volunteers.

Drug: Placebo; Drug: MWX203 S5

MWX203 Cohort 6

EXPERIMENTAL

Escalating doses of MWX203 or Matching placebo were administered via subcutaneous injection to healthy volunteers.

Drug: Placebo; Drug: MWX203 S6

Interventions

MWX203 S1 DRUG

administered subcutaneously (SC)

MWX203 Cohort 1

Placebo DRUG

administered SC

MWX203 Cohort 1; MWX203 Cohort 2; MWX203 Cohort 3; MWX203 Cohort 4; MWX203 Cohort 5; MWX203 Cohort 6

MWX203 S2 DRUG

administered SC.

MWX203 Cohort 2

MWX203 S3 DRUG

administered SC.

MWX203 Cohort 3

MWX203 S5 DRUG

administered SC.

MWX203 Cohort 5

MWX203 S6 DRUG

administered SC.

MWX203 Cohort 6

MWX203 S4 DRUG

administered SC.

MWX203 Cohort 4

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male and female subjects aged 18 to 55 years (inclusive) at the time of signing the informed consent form (ICF).
• 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.
• 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.
• 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.
• 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.
• 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.

You may not qualify if:

• 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).
• Serious trauma or major surgery (requiring general anesthesia) within 6 months prior to screening, or planned major surgery during the study.
• 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).
• QTcF ≥ 450 ms (male) or ≥ 470 ms (female) at screening; or clinically-significant abnormalities on the 12-lead electrocardiogram.
• HbA1c \> ULN.
• Overall atherosclerotic cardiovascular disease (ASCVD) risk assessed by the investigator as moderate or high risk at screening.
• Use of any liver-targeted oligonucleotide drug within 1 year prior to screening.
• Pregnant or lactating female subjects at screening.
• 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.
• 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).
• 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.
• Any other condition judged by the investigator to make the subject unsuitable for participation in this study.

Sponsors & Collaborators

• Shanghai Minwei Biotechnology Co., Ltd: lead

Study Sites (1)

Hangzhou First People's Hospital

Hangzhou, Zhejiang, China

Location

Study Design

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

Study Record Dates

• First Submitted: August 24, 2026
• First Posted: September 2, 2026
• Study Start: July 7, 2025
• Primary Completion: March 7, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: September 2, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)