Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Patients
Launched by CYCLARITY THERAPEUTICS, INC. · Feb 3, 2025
Trial Information
Current as of July 22, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new medication called UDP-003 to see if it is safe and effective for treating conditions related to heart disease, such as atherosclerotic cardiovascular disease and acute coronary syndromes. The researchers want to find out how the body processes this medication and its possible benefits. Participants in the study will receive either UDP-003 or a placebo (a harmless pill with no active ingredients) without knowing which one they are getting. The trial has three parts: healthy volunteers will first receive single doses, then multiple doses over 16 days, and finally, patients diagnosed with acute coronary syndrome will receive multiple doses over the same period.
To join the study, healthy adults aged 18 to 45 and patients aged 40 to 59 who have had heart issues at least a year ago may be eligible, but they must meet specific health criteria. Healthy participants should not have significant underlying health problems, while patients must be stable on their heart treatments. Each participant will have different time commitments based on their group, with follow-up periods to monitor their health after receiving the medication. This trial aims to ensure safety and gather valuable information about UDP-003's effects on heart health.
Gender
ALL
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.
About Cyclarity Therapeutics, Inc.
Cyclarity Therapeutics, Inc. is a biopharmaceutical company dedicated to advancing innovative therapies for the treatment of complex medical conditions. With a strong focus on precision medicine, Cyclarity leverages cutting-edge research and technology to develop novel drug candidates aimed at improving patient outcomes. The company is committed to rigorous scientific standards and ethical practices in its clinical trials, striving to address unmet medical needs through collaboration and a patient-centered approach. By harnessing the potential of emerging scientific advancements, Cyclarity Therapeutics aims to transform the landscape of therapeutic options available to healthcare providers and patients alike.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Adelaide, South Australia, Australia
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported