Testing UDP-003 for safety and effectiveness in healthy individuals and patients with heart conditions

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

This study is testing a new drug called UDP-003 to see if it's safe and effective for both healthy people and those with heart conditions, specifically looking at its ability to reduce plaque buildup in the arteries.

Quick facts

• Phase: Early Phase 1
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years to 79 Years
• Sex: All
• Sponsor: Cyclarity Therapeutics, Inc. (Industry-sponsored)
• Locations: 1 site (Adelaide, South Australia)
• Trial ID: NCT06813339 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and pharmacokinetics of UDP-003 in both healthy participants and patients with acute coronary syndrome. The study is designed as a randomized, double-blind, placebo-controlled trial and consists of three parts: single ascending doses in healthy participants, multiple ascending doses in healthy participants, and multiple doses in patients diagnosed with acute coronary syndrome. The trial will assess the drug's potential efficacy in reducing plaque burden in patients with cardiovascular disease. Safety data will be reviewed before escalating doses in the trial.

Who should consider this trial

Good fit: Ideal candidates include healthy adults aged 18 to 55 and adults aged 40 to 79 with a history of acute coronary syndrome at least 12 months post-event.

Not a fit: Patients with significant comorbidities or those not meeting the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to new treatment options for reducing plaque burden in patients with atherosclerotic cardiovascular disease.

How similar studies have performed: While this approach is novel in its specific application, similar studies have shown promise in evaluating new treatments for cardiovascular conditions.

Eligibility criteria

Inclusion Criteria:

(Healthy Participants (SAD and MAD cohorts)):

* Healthy adult males and females, 18 to 55 years of age (inclusive) at the time of screening.
* Medically healthy with relevant renal parameters tests not exceeding 1.5 X the upper limits and no clinically significant screening results (e.g., laboratory profiles, medical history, vital signs, ECGs, physical examination) as deemed by the Principal Investigator; one retest is permitted at investigator discretion.

(Participants with ACS (MD Patient cohort):

* Adult males and females, 40 to 79 years of age (inclusive) at the time of screening, diagnosed with acute coronary syndrome (ACS), at least 12 months post event (NSTEMI or unstable angina).
* Medically stable with no clinically significant screening results (e.g., laboratory profiles including relevant renal parameters and liver function tests, medical history, vital signs, ECGs, physical examination) as deemed by the Principal Investigator.
* Participants on a stable regimen and dose of ACS treatment including statins, anticoagulants, blood thinners, anti-platelets or other standard of care for 3 months prior to screening and for whom no change in this treatment is planned during the participation in the study.

Exclusion Criteria:

(Healthy Participants (SAD and MAD cohorts)):

* History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease as deemed by the Principal Investigator.
* History of myocardial infarction (MI), transient ischemic attack (TIA), stroke, or familial history of coronary artery disease or first-degree heart attack below the age of 60.
* Any clinically significant ECG abnormality at Screening
* Diabetic participants

(Patients (MD cohort):

* Percutaneous coronary intervention or diagnostic angiogram planned after screening.
* Documented episode of post-MI pericarditis in the 3 months before enrollment.
* Ongoing heart failure as defined by Class IV New York Heart Association
* History or presence of significant pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
* Ongoing infection or febrile illness.
* Ongoing atrial fibrillation or flutter.
* History of MI, TIA, or stroke diagnosed within the 12 months prior to screening.
* History of or planned coronary artery bypass grafting.
* Any cardiac intervention or cardiac hospitalization in the past 12 months
* Any clinically significant ECG abnormality at Screening.
* Participants with contraindications to CTA.

Where this trial is running

Adelaide, South Australia

• CMAX Clinical Research — Adelaide, South Australia, Australia (Recruiting)

Study contacts

• Study coordinator: Daniel M Clemens, Ph.D.

Conditions Atherosclerotic Cardiovascular Disease; Acute Coronary Syndromes; Atherosclerosis; 7-ketocholesterol; Cyclodextrin; Plaque burden reduction; Healthy Participants; Acute coronary syndrome