About this trial
The goal of this clinical trial is to learn if UDP-003 is safe in healthy human participants and patients, assess the pharmacokinetics (PK)/pharmacodynamics (PD) of UDP-003 in healthy human participants and patients and its potential efficacy in patients.
Researchers will compare UDP-003 to a placebo in a blinded manner.
This first in human, randomised, double-blind, placebo-controlled, prospective, single-centre trial with a modular dose-finding design will be conducted in 3 parts:
* Part 1: 6 cohorts of 6 healthy participants receiving Single Ascending Doses (SADs), * Part 2: 3 cohorts of 12 healthy participants receiving Multiple Ascending Doses (MADs) (6 doses over 16 days), * Part 3: 1 cohort of up to 9 evaluable participants diagnosed with acute coronary syndrome (ACS; non-ST elevation myocardial infarction \[NSTEMI\] or unstable angina) at least 12 months post-event receiving multiple doses (6 administrations of the 25 mg/kg dose over 6 weeks).
The planned duration of the study for each participant will be:
* 4 weeks for SAD Participants (1-day treatment period, 4-week safety follow-up) * 6 weeks for MAD Participants (16-day treatment period,4-week safety follow-up) * 180 Days for MD Patients (6-week treatment period, 6-month safety follow-up) Prior to participants being randomised to panels of increasing doses, all safety data will be reviewed for completed panels.
Eligibility criteria
Qualifiers
Participant understands study procedures and provides written informed consent for the trial.
Participant is able to comply with the protocol and the assessments therein.
Healthy adult males and females, 18 to 65 years of age (inclusive) at the time of screening.
Adult males and females of body mass index (BMI) ≥ 18 and ≤ 32 kg/m² and body weight ≥ 50 and ≤ 120 kg.
Disqualifiers
None
Trial design
Treatments tested in this trial
- UDP-003
- Placebo
Treatment groups
Sponsors and collaborators
Cyclarity Therapeutics, Inc.
Lead sponsor
Monash University
Collaborator