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Clinical Trials in Australia / NCT07864311
Starting soon Phase 1

A Phase 1 Study of VELA-101 in Adult Participants

NCT07864311 · tracked via the Priya Life Science Australia tracker
Sponsor
Ursa Medicines
Phase
Phase 1
Started
2026-11
Last updated
2026-10-15

Condition(s) studied

Healthy ParticipantsHyperlipidemia

Investigational drug(s) / intervention(s)

VELA-101Placebo

VELA-101: subcutaneous injection

Placebo: subcutaneous injection

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

  • To evaluate the safety and tolerability of single ascending doses of VELA-101, as assessed by the incidence and severity of treatment-emergent adverse events and vital signs, electrocardiogram, and and clinical laboratory parameters — Day 180
    Incidence, severity, and relationship of treatment-emergent adverse events and changes from baseline in vital signs, electrocardiogram parameters, and clinical laboratory parameters

Trial sites (2)

FacilityCityRegionStatus
University of Sunshine Coast Morayfield Queensland
Linear Clinical Research Nedlands Western Australia

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07864311 on ClinicalTrials.gov ↗ ← All trials in Australia