New heart drug UDP-003 enters first human safety tests

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.