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%).
Parallel
MWX205
DrugEach 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.
Placebo
DrugMatching placebo
Incidence of TEAEs
Incidence of SAEs
Number of participants with abnormal vital signs
Vital signs include tympanic body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate
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
Plasma PK parameters Cmax (Maximum observed plasma drug concentration directly determined from the plasma concentration-time profiles)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Plasma PK parameters- Tmax (Time to maximum observed plasma drug concentration)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Plasma PK parameters- AUC0-inf (Area under the plasma concentration-time curve from time 0 extrapolated to infinity.)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Plasma PK parameters- AUC0-last (Area under the plasma concentration-time curve, from time zero to the last time point with measurable analyte concentration)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
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This trial is not recruiting at the moment. You can still explore other options:
