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?
This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study in which the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of MWX205 Injection will be assessed in adult participants with dyslipidemia. Overall, 37 participants will be enrolled and assigned to 5 sequential cohorts (Cohorts 1 through 5). Cohort 1 will enroll 5 participants and be randomized 3:2 to receive a single dose of MWX205 or placebo (3 participants receiving MWX205 and 2 receiving a placebo). Cohorts 2 to 5 will be comprised of 8 participants per Cohort and randomized 3:1 to receive a single dose of MWX205 or placebo, respectively (6 participants receiving MWX205 Injection and 2 receiving a placebo). Dosing in each cohort will be such that 2 participants (1 MWX205 Injection and 1 placebo) will be administered at least 24 hours before the remaining 3 participants (the first cohort) or 6 participants (cohorts 2-5). After dosing the first 2 participants on a separate day, a minimum of a 5-minute dosing interval for the remaining 3 participants (the first cohort), or 6 participants (cohorts 2-5) in the following cohort, is considered acceptable. Continuation to dose the remaining 3 participants (Cohort 1) or 6 participants (Cohorts 2-5) will be at the investigator's discretion. Each participant will participate in 1 cohort only, residing at the Clinical Research Unit (CRU) from Day -1 (the day before dosing) to Day 8.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
37
Incidence of TEAEs
Time frame: From Day 1 to Day 86
Incidence of SAEs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From Day 1 to Day 337
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
Time frame: Day 1, Day 2, Day 3
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
Time frame: Day 1, Day 2, Day 3
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
Time frame: 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)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Time frame: Day 1, Day 2, Day 3
Urine PK parameters- Fe (dose fraction of the drug in its original form excreted in urine after administration)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Time frame: Day 1, Day 2, Day 3
Urine PK parameters- Ae (cumulative excretion of the drug's original form in urine)
Non-compartmental analysis (NCA) will be used to calculate the PK parameters with Phoenix WinNonlin Software
Time frame: Day 1, Day 2, Day 3
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