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.
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.
None
Parallel
UDP-003
DrugThe UDP-003 finished product is clear, colourless to yellow liquid that is intended to be a sterile solution for IV bolus push administration in sterile water at a concentration of 300 mg/mL.
Placebo
Other interventionPlacebo will be provided as a sterile clear, colourless solution formulated to match viscosity of the UDP-003 solution.
Safety outcome measures (Adverse Events)
Occurrence of adverse events (AEs) of any type and severity
Safety outcome measures (Vital Signs: Systolic Blood Pressure)
SBP will be measured in mmHg
Safety outcome measures (Vital Signs: Diastolic Blood Pressure)
DBP will be measured in mmHg
Safety outcome measures (Vital signs: Heart Rate)
Heart Rate will be measured in bpm
Pharmacokinetics Outcome Measures (Cmax)
The maximum concentration achieved by UDP-003 in a specified compartment area of the body after the drug has been administered and before the administration of a second dose
Pharmacokinetics Outcome Measures (Tmax)
Time at which maximum concentration of UDP is reached
Pharmacokinetics Outcome Measures (half-life (t1/2))
The estimate of the time it takes for the concentration or amount in the body of that drug to be reduced by exactly one-half (50%).
Pharmacokinetics Outcome Measures (AUC0-t and AUC0-inf)
Area under the concentration curve (AUC0-t and AUC0-inf) reflects the actual body exposure to drug after administration of a dose of the drug and is expressed in mg\*h/L
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Cyclarity Therapeutics, Inc.
Lead sponsor
Monash University
Collaborator
