Actively Recruiting
A Double Blind, Placebo-controlled Study to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Patients
Led by Cyclarity Therapeutics, Inc. · Updated on 2026-02-24
84
Participants Needed
1
Research Sites
47 weeks
Total Duration
On this page
Sponsors
C
Cyclarity Therapeutics, Inc.
Lead Sponsor
M
Monash University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying UDP-003, a drug being tested for safety and potential benefits in healthy adults and patients with a history of acute coronary syndrome (ACS). The study aims to understand the drug's behavior in the body and its possible effects on reducing plaque buildup in patients who had a non-ST elevation myocardial infarction or unstable angina at least 12 months prior. This early-phase trial is randomized, double-blind, and placebo-controlled, conducted at a single center with a modular dose-finding design. The trial includes three parts: Part 1 involves six groups of healthy participants receiving single ascending doses (SADs); Part 2 involves three groups of healthy participants receiving multiple ascending doses (MADs) over 16 days; and Part 3 includes patients with ACS receiving multiple doses of UDP-003 at 25 mg/kg over six weeks. Participants are randomly assigned to receive either UDP-003 or a matching placebo through intravenous bolus injections. The dosing volume is adjusted based on body weight, and doses are carefully escalated after safety reviews. The placebo matches the active drug's appearance and volume. Participants will undergo treatment and follow-up periods varying by group: SAD participants receive treatment in one day with a 4-week safety follow-up; MAD participants receive doses over 16 days plus a 4-week safety follow-up; and patient participants receive six doses over six weeks followed by a 6-month safety follow-up. Throughout the study, researchers monitor safety through vital signs, laboratory tests, ECGs, audiometry, and assessments of injection site reactions. Pharmacokinetics are assessed on dosing days to understand how the drug moves through and is cleared from the body.
CONDITIONS
Brief Title
Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy adult males and females aged 18 to 55 years for single and multiple ascending dose cohorts.
- Adults aged 40 to 79 years diagnosed with acute coronary syndrome (NSTEMI or unstable angina) at least 12 months before screening for the patient cohort.
- Medically healthy or medically stable as determined by the Principal Investigator.
- For patient cohort, stable regimen and dose of ACS treatment including statins, anticoagulants, blood thinners, or antiplatelets for at least 3 months before screening with no planned changes during the study.
You will not qualify if you...
- History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease in healthy participants.
- History of myocardial infarction, transient ischemic attack, stroke, or family history of coronary artery disease before age 60 in healthy participants.
- Clinically significant ECG abnormalities at screening.
- Diabetes in healthy participants.
- Planned percutaneous coronary intervention or angiogram after screening in patient cohort.
- Post-MI pericarditis episode within 3 months before enrollment.
- Ongoing heart failure classified as Class IV NYHA.
- Significant other diseases or ongoing infection.
- Ongoing atrial fibrillation or flutter.
- MI, TIA, or stroke diagnosed within 12 months prior to screening.
- Planned or history of coronary artery bypass grafting.
- Cardiac intervention or hospitalization within past 12 months.
- Contraindications to CTA imaging in patient cohort.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 6 weeks depending on cohort
Participants receive single or multiple ascending doses of UDP-003 or placebo via intravenous injection to assess safety and pharmacokinetics.
Up to 6 dosing visits depending on cohort
Duration - Up to 28 weeks depending on cohort
Participants are monitored for safety and clinical outcomes following the last dose administration.
Follow-up visits scheduled as per protocol
Trial Site Locations
Total: 1 location
1
CMAX Clinical Research
Adelaide, South Australia, Australia, 5000
Actively Recruiting
Research Team
D
Daniel M Clemens, Ph.D.
M
Matthew O'Connor, Ph.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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