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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion Criteria

All Participants:

1. Participant understands study procedures and provides written informed consent for the trial.
2. Participant is able to comply with the protocol and the assessments therein.

Healthy Participants (SAD and MAD cohorts):

1. Healthy adult males and females, 18 to 65 years of age (inclusive) at the time of screening.
2. Adult males and females of body mass index (BMI) ≥ 18 and ≤ 32 kg/m² and body weight ≥ 50 and ≤ 120 kg.
3. Social smoking of less than 10 nicotine-containing products per month is acceptable. Absence of tobacco or nicotine containing product (including smoking cessation products) use, for a minimum of 2 weeks prior to dosing is required and will be confirmed by a negative cotinine test at check-in (one retest allowed at the discretion of the investigator).
4. 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):

1. 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).
2. Adult males and females of body mass index (BMI) ≥ 18
3. 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.
4. 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.

Where it's running

• CMAX Clinical Research
  Adelaide, South Australia, Australia Recruiting
• Emeritus Research Camberwell
  Camberwell, Victoria, Australia Not yet recruiting
• ACS Research Pty Ltd
  Melbourne, Victoria, Australia Not yet recruiting

Study contacts

• Study coordinator: Daniel M Clemens, Ph.D.
• Email: info@cyclaritytx.com
• Phone: (707) 200-3610

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.