A Phase 1 Study of VELA-101 in Adult Participants

This is a first-in-human (FIH), multicenter, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of VELA-101, following single-ascending doses via subcutaneous (SC) administration.

Key Inclusion Criteria (All Parts): * Participants must be adults able to understand the study, provide written informed consent, and comply with study procedures. * Age: Part A: 18-55 years; Part B: 18-65 years * BMI and body weight: Part A: BMI 18.0-30.0 kg/m²; Part B: BMI 18.0-35.0 kg/m² * Considered medically healthy based on medical history and screening assessments. * Male and Female participants must agree to contraception requirements. Key Inclusion Criteria (Part B): \- Elevated LDL-C and Lipoprotein(a) Key Exclusion Criteria (All Parts): * Known familial hypercholesterolemia or severe hypertriglyceridemia. * Clinically significant cardiovascular, liver, kidney, immune, or other medical disease. * Positive screening for HIV, hepatitis B, or hepatitis C. * Current significant infection, substance misuse, or other condition that could interfere with study participation. Key Exclusion Criteria (Part B): * Uncontrolled type 2 diabetes. * Recent changes in lipid-lowering therapy. * History of significant cardiovascular disease, including myocardial infarction, stroke, heart failure, significant arrhythmia, or uncontrolled hypertension.