Healthy ParticipantsPhase 1NCT07864311
A Phase 1 Study of VELA-101 in Adult Participants
A Phase 1 study testing VELA-101 in people with Healthy Participants and Hyperlipidemia, run by Ursa Medicines at 2 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Hyperlipidemia
- What is being tested?
- VELA-101
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesAustralia
- Study dates
- Nov 2026to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
- Elevated LDL-C and Lipoprotein(a)
Who cannot join
- 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.
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia2 sites
University of Sunshine Coast
Morayfield, Queensland
Linear Clinical Research
Nedlands, Western Australia
About this study
Official title: A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics 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.
Read the detailed description
The study consists of 2 sequential parts:
- Part A: Single-ascending doses in healthy participants
- Part B: Single-ascending doses in participants with hyperlipidemia
- Conditions
- Healthy Participants, Hyperlipidemia
- Being tested
- VELA-101, Placebo
- Medical subject headings
- Hyperlipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VELA-101Drug
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| VELA-101 in Healthy Adult Participants | Experimental | Part A Receives: Drug: VELA-101 |
| In Healthy Adults | Placebo comparator | Part A Receives: Drug: Placebo |
| VELA-101 in Participants with Hyperlipidemia | Experimental | Part B Receives: Drug: VELA-101 |
| In Participants with Hyperlipidemia | Placebo comparator | Part B Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Incidence, severity, and relationship of treatment-emergent adverse events and changes from baseline in vital signs, electrocardiogram parameters, and clinical laboratory parameters
Measured: Day 180
Secondary outcomes (3)
To characterise the plasma pharmacokinetics of single ascending doses of VELA-101
Plasma concentrations of VELA-101
Measured: Day 1 to Day 3
To characterise the urine pharmacokinetics of single ascending doses of VELA-101
Urine concentrations of VELA-101
Measured: Day 1 to Day 3
To evaluate the effect of VELA-101 on lipid parameters following a single SC administration
Change from baseline in blood lipid parameters
Measured: Up to Day 360
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ursa Medicines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864311
- Sponsor's protocol ID
- VELA-101-1101
- Status last verified
- Oct 2026
- First submitted
- 2 Oct 2026
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data has not yet been finalized. Any future data sharing will be considered in accordance with applicable regulatory requirements, participant consent, data privacy obligations, and sponsor policies.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Randomised, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VELA-101 in Adult Participants
- ClinicalTrials.gov ID
- NCT07864311
- Acronym / sponsor ID
- VELA-101-1101
- Conditions
- Healthy Participants, Hyperlipidemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ursa MedicinesIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 7 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The study consists of 2 sequential parts:
- Part A: Single-ascending doses in healthy participants
- Part B: Single-ascending doses in participants with hyperlipidemia
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| VELA-101 in Healthy Adult Participants | Experimental | Drug: VELA-101Part A |
| In Healthy Adults | Placebo comparator | Drug: PlaceboPart A |
| VELA-101 in Participants with Hyperlipidemia | Experimental | Drug: VELA-101Part B |
| In Participants with Hyperlipidemia | Placebo comparator | Drug: PlaceboPart B |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 exclusion criteria (7 listed)
- 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.
- Uncontrolled type 2 diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VELA-101subcutaneous injection | Drug | VELA-101 in Healthy Adult Participants, VELA-101 in Participants with Hyperlipidemia |
| Placebosubcutaneous injection | Drug | In Healthy Adults, In Participants with Hyperlipidemia |
Primary outcome
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
Time frame: Day 180
Incidence, severity, and relationship of treatment-emergent adverse events and changes from baseline in vital signs, electrocardiogram parameters, and clinical laboratory parameters
3 secondary outcomes
To characterise the plasma pharmacokinetics of single ascending doses of VELA-101
Time frame: Day 1 to Day 3
To characterise the urine pharmacokinetics of single ascending doses of VELA-101
Time frame: Day 1 to Day 3
To evaluate the effect of VELA-101 on lipid parameters following a single SC administration
Time frame: Up to Day 360
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data has not yet been finalized. Any future data sharing will be considered in accordance with applicable regulatory requirements, participant consent, data privacy obligations, and sponsor policies.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VELA-101 in people with Healthy Participants and Hyperlipidemia, run by Ursa Medicines at 2 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Director (617-798-2120, clinicaltrials@ursameds.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Day 180). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.