A Phase 1 Study to Assess Safety and Effects of the New Injectable Drug COR-1004 on Bad Cholesterol in Adults

What this Trial Is About

Researchers are evaluating a new injectable drug called COR-1004 for adults with high LDL cholesterol 100 mgdL or higher who are otherwise healthy and not taking cholesterol-lowering medicines. This early-phase study aims to find out if COR-1004 is safe, determine the highest dose without serious side effects, understand how the body processes the drug, and observe its effects on bad cholesterol levels. The information will help decide if larger studies are needed in the future. Participants will receive a single subcutaneous injection of COR-1004 or a placebo in groups of ten. Most participants in each group will get the study drug, while a few will receive a placebo to help understand the drugs true effects. The study uses a randomized, double-blind design and tests increasing dose levels, starting with a low dose. The first two people in each new dose group will be monitored for 24 hours before others receive the injection to ensure safety. After the injection, participants will visit the clinic multiple times over one year for health checks, physical exams, and blood tests to monitor safety and cholesterol levels. Experts will oversee the study to protect participants. Researchers will track any side effects, drug behavior in the body, and changes in cholesterol. Participants involvement lasts about 12 months, including follow-up and safety monitoring.

A Study to Evaluate COR-1004 in Adult Volunteers.