An Early Phase 1 interventional study of UDP-003 and Placebo in Atherosclerotic Cardiovascular Disease and Acute Coronary Syndromes, sponsored by Cyclarity Therapeutics, Inc.. Recruiting at 3 sites in Australia. Open to participants aged 18 Years to 79 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Cyclarity Therapeutics, Inc. · Early Phase 1, Interventional, and Treatment
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:
The planned duration of the study for each participant will be:
This trial's objective will be to collect the preliminary clinical safety and clinical pharmacology data. The study objective in the patient cohort is obtaining preliminary information on the safety of UDP-003 in those carrying a detectable plaque burden and obtaining preliminary indication of efficacy in respect to reducing the plaque burden.
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:
Prior to participants being randomised to panels of increasing doses, all safety data will be reviewed for completed panels. Within each dose group in the SAD portion of the study, sentinel dosing will be implemented wherein 2 participants (1 active, 1 placebo) will be dosed at least 24 hours before the remaining participants in the cohort. Dosing in the MAD portion of the study will commence only after the Data Safety Monitoring Committee (DSMC) reviews the safety data from the 5th (20 mg/kg) SAD cohort.
Investigational Products A. UDP-003, formulated as a sterile solution for injection, 300 mg/mL. Volume of administration is weight dependent and target doses are 1-25 mg/kg.
B. Placebo formulated as sterile solution for injection. Volume injected will match the volumes of UDP-003 for each panel and each participant.
The investigational products will be administered as intravenous (IV) bolus push injection, in a blinded manner to sitting or supine participants. Doses lower than the highest dose will be diluted with vehicle (identical to placebo) to ensure the same dosing volume per body mass across placebo and active groups. No fasting is required.
In the MD panels, a single IV bolus push injection will be administered on Days 1, 8,15, 22, 29 and 36.
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
This study's planned enrollment of 84 is below the median of 100 across 879 interventional studies indexed under Atherosclerosis.
Browse Atherosclerosis studies →This is the only study on the registry with Cyclarity Therapeutics, Inc. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
All Participants:
Healthy Participants (SAD and MAD cohorts):
Participants with ACS (MD Patient cohort):
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
UDP-003 will be administered to the participants randomised to this arm. UDP-003 is a formulated as a sterile solution for injection, 300 mg/mL. Volume of administration is weight dependent and target doses are 1-25 mg/kg.
Drug: UDP-003
Placebo will be administered to the participants randomised to this arm. Placebo formulated as sterile solution for injection. Volume injected will match the volumes of UDP-003 for each panel and each participant.
Other: Placebo
The 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 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
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Safety outcome measures (Vital Signs: Systolic Blood Pressure)
SBP will be measured in mmHg
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Safety outcome measures (Vital Signs: Diastolic Blood Pressure)
DBP will be measured in mmHg
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Safety outcome measures (Vital signs: Heart Rate)
Heart Rate will be measured in bpm
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Safety outcome measures (Vital signs: Respiratory Rate)
RR will be measured in rpm
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Safety outcome measures (Vital signs: Temperature)
Body temperature will be measured in Celsius (0C)
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Safety outcome measures (Clinical Laboratory Parameters)
For parameters outside of the reference range an assessment of the significance (clinically significant / non-clinically significant) will be provided and all data outside the reference range of the clinical laboratory will be listed for all study participants
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Safety outcome measures (ECG QTCF Interval)
The QTcF interval will be calculated using the formula QTcF = QT/√R-R interval in seconds
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Safety outcome measures (Injection site reactions)
Assessment for signs of phlebitis, extravasation, infection and pain before, during and after intravenous administration is vital to ensure the patency and viability of the vein. The reactions will be assessed using the current FDA Toxicity Grading Scale provides a measure for classifying injection site AEs by four grades \[Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe) and Grade 4 (life threatening)\].
Time frame: From first dose administration (Day 1) through From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Safety outcome measures (Audiometry: PTA)
Air/Bone Pure-tone audiometry (PTA) conduction testing will be done at 250, 500, 1000, 3000, 4000, 6000 and 8000Hz
Time frame: From enrolment through 24 hours post dose for SAD Participants (Day 2), 24 hours post dose for MAD and MD Patients Participants (Day 17),
Safety outcome measures (Audiometry: HFA)
Bone/Air High-frequency audiometry (HFA) conduction testing will be done at 9000, 10 000, 11200 and 12500Hz, Tympanometry, Self-evaluation questionnaires (tinnitus handicap inventory \[THI\] and dizziness handicap inventory \[DHI\])
Time frame: From enrolment through 24 hours post dose for SAD Participants (Day 2), 24 hours post dose for MAD and MD Patients Participants (Day 17),
Safety outcome measures (Audiometry: Self-evaluation questionnaire (THI))
Self-evaluation questionnaire: using Tinnitus Handicap Inventory \[THI\] questionnaire
Time frame: From enrolment through 24 hours post dose for SAD Participants (Day 2), 24 hours post dose for MAD and MD Patients Participants (Day 17),
Safety outcome measures (Audiometry: Self-evaluation questionnaire (DHI))
Self-evaluation questionnaire: using Dizziness Handicap Inventory \[DHI\] questionnaire
Time frame: From enrolment through 24 hours post dose for SAD Participants (Day 2), 24 hours post dose for MAD and MD Patients Participants (Day 17),
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
Time frame: Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Pharmacokinetics Outcome Measures (Tmax)
Time at which maximum concentration of UDP is reached
Time frame: Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
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%).
Time frame: Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
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
Time frame: Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Pharmacokinetics Outcome Measures (Total Plasma Clearance (CL))
The volume of drug cleared from blood or plasma in unit time
Time frame: Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Pharmacokinetics Outcome Measures (Volume of Distribution (Vd))
The participant's drug's propensity to either remain in the plasma or redistribute to other tissue compartments
Time frame: Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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