Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWX205

NCT07634510 | Not Yet Recruiting Phase 1

• 1 other identifier: MWX205-101
• Study Type: interventional
• Target: 37
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is being done to test a new injection called MWX205 in people with high cholesterol or fat levels in the blood (dyslipidemia). Researchers will check if a single dose of MWX205 is safe and how the body reacts to it. They will also measure how quickly the drug enters the bloodstream and how long it stays in the body, and compare it with a placebo (inactive treatment). The study will help decide the right dose and understand how this medicine could be used in future treatments. The main questions this study aims to answer are:

1. 1.Is MWX205 safe after a single dose?
2. 2.How does the body process MWX205?
3. 3.Does MWX205 show any effect on the body related to cholesterol levels?

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (5)

• Incidence of TEAEs

  From Day 1 to Day 86

• Incidence of SAEs

  From Day 1 to Day 86

• Number of participants with abnormal vital signs

  Vital signs include tympanic body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate

  From Day 1 to Day 86

• Number of participants with abnormal Physical examination findings

  Complete physical examinations include general appearance, mouth/dental (if required), neck (including thyroid \& nodes), cardiovascular, respiratory, gastrointestinal, renal, neurological, musculoskeletal, skin, other

  From Day 1 to Day 337

• Number of participants with abnormal ECG readings

  12 Lead ECG: Triplicate readings to be taken within 2 to 5 minutes of each other. ECGs are to be taken after the participant has rested in the supine position for ≥ 5 minutes

  From Day 1 to Day 337

Secondary Outcomes (6)

• Plasma PK parameters Cmax (Maximum observed plasma drug concentration directly determined from the plasma concentration-time profiles)

  Day 1, Day 2, Day 3

• Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration)

  Day 1, Day 2, Day 3

• Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.)

  Day 1, Day 2, Day 3

• Plasma PK parameters- AUC0-last (Area under the plasma concentration-time curve, from time zero to the last time point with measurable analyte concentration)

  Day 1, Day 2, Day 3

• Urine PK parameters- Fe (dose fraction of the drug in its original form excreted in urine after administration)

  Day 1, Day 2, Day 3

Study Arms (2)

MWX205

EXPERIMENTAL

Strength: 1ml: 200 mg Proposed dose levels for SAD study: 50, 200, 400, 800, and 1200 mg Administration: subcutaneous injection, recommended in the abdomen.

Drug: MWX205

Placebo

PLACEBO COMPARATOR

Administration: subcutaneous injection, recommended in the abdomen.

Drug: Placebo

Interventions

MWX205 DRUG

Each vial contains 200mg of MWX205 small nucleic acid, with water for injection as the solvent. The excipient, including sodium hydroxide and/or hydrochloric acid, may be added to adjust the pH to 6.5±0.2.

MWX205

Placebo DRUG

Matching placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult participants with dyslipidemia will be enrolled in this study.
• The absence of clinically significant illness and surgery within 4 weeks prior to study drug administration.
• Participants must have fasting triglycerides greater than or equal to 150 mg/dL (1.7 mmol/L) and less than 500 mg/dL (5.7 mmol/L), and LDL-C greater than or equal to 70 mg/dL (1.8 mmol/L) at pre-screening and confirmation within 7 days before randomization.
• Have a body mass index within the range 18.5 to 40.0 kg/m2 (inclusive), with no plans to significantly alter diet or BMI over the course of study.
• Females of childbearing potential and males who are not surgically sterile (\> 90 days since vasectomy with no viable sperm) will agree to use contraception from Screening until 6 months after the administration, OR females of non-reproductive potential

You may not qualify if:

• Positive pregnancy test or lactating female participant.
• Systolic BP lower than 90 or over 140 mmHg, diastolic BP lower than 40 or over 90 mmHg, HR less than 40 or over 100 bpm at screening.
• QTcF over 450 ms at screening.
• Consume more than 7 units for women or 14 units for men of alcohol per week within 8 weeks prior to screening (1 unit = 285 mL of beer 3.5%, 75 mL of wine 13.5%, or 25 mL of distilled alcohol 40%).
• Participants with established coronary artery disease, peripheral arterial disease, prior stroke, or other clinically significant atherosclerotic cardiovascular disease (such as stent placement or heart bypass, unstable angina or last known ejection fraction of \<50%).
• History of intolerance to SC injection or relevant abdominal scarring (surgical, burns, etc.), or any skin conditions, including infections or open wounds, or dermatitis at the injection site that could interfere with the evaluation of injection reaction.
• Have taken any prescription medications that are specifically indicated for lowering serum TGs (e.g., fibric acid derivatives, niacin, and omega-3 fatty acids \[\>1 g/day\]) or medications that interfere with absorption of dietary cholesterol or fats (e.g., bile acid sequestrants, orlistat) within 2 months prior to screening.
• Have received treatment with any liver-targeted siRNA therapy or ASO (Antisense Oligonucleotide) within12 months prior to screening.
• Use of ANGPTL3 or PCSK9-inhibiting monoclonal antibodies within 90 days prior to screening.
• Use of systemic glucocorticoid therapy for more than 14 consecutive days in the past year, or any glucocorticoid therapy (excluding topical, intra-ocular, intra-articular, intranasal, or inhaled preparations) within 1 month before screening.

Sponsors & Collaborators

• Shanghai Minwei Biotechnology Co., Ltd: lead

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Mohd Naguib bin Mohd Yunos, Dr.

  Veritus Research

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohd Naguib bin Mohd Yunos, Dr.

CONTACT

+61 0387361750; naguibyunos@veritusresearch.com

Study Design

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

Study Record Dates

• First Submitted: June 4, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): June 22, 2026
• Primary Completion (Estimated): October 26, 2026
• Study Completion (Estimated): November 8, 2027
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share