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. Is MWX205 safe after a single dose? 2. How does the body process MWX205? 3. Does MWX205 show any effect on the body related to cholesterol levels?
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.
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%).
Shanghai Minwei Biotechnology Co., Ltd
Lead sponsor