A Phase 1 Study of VELA-101 in Adult Participants
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUrsa Medicines
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
VELA-101
Drugsubcutaneous injection
Placebo
Drugsubcutaneous injection
Treatment groups
60 Participants
are divided into 4 treatment groupsGroup A: VELA-101 in Healthy Adult ParticipantsExperimental treatment 1 intervention
Group B: In Healthy AdultsPlacebo comparator 1 intervention
Group C: VELA-101 in Participants with HyperlipidemiaExperimental treatment 1 intervention
Group D: In Participants with HyperlipidemiaPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
To evaluate the safety and tolerability of single ascending doses of VELA-101
Incidence, severity, and relationship of treatment-emergent adverse events and changes from baseline in vital signs, electrocardiogram parameters, and clinical laboratory parameters
Time frame
Day 180Secondary outcomes
1
To characterise the plasma pharmacokinetics of single ascending doses of VELA-101
Plasma concentrations of VELA-101
Time frame
Day 1 to Day 32
To characterise the urine pharmacokinetics of single ascending doses of VELA-101
Urine concentrations of VELA-101
Time frame
Day 1 to Day 33
To evaluate the effect of VELA-101 on lipid parameters following a single SC administration
Change from baseline in blood lipid parameters
Time frame
Up to Day 360Sponsors and contacts
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Source ClinicalTrials.gov
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