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Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MWX205
Sponsor: Shanghai Minwei Biotechnology Co., Ltd
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. 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?
Official title: A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneously Administered MWX205 Injection in Adult Participants With Dyslipidemia
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
37
Start Date
2026-06-22
Completion Date
2027-11-08
Last Updated
2026-06-10
Healthy Volunteers
No
Conditions
Interventions
MWX205
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.
Placebo
Matching placebo