Atherosclerotic Cardiovascular DiseaseEarly Phase 1CTx-001NCT06813339
Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Followed by an Open-label Patient Cohort
A Early Phase 1 study testing UDP-003 in people with Atherosclerotic Cardiovascular Disease and Acute Coronary Syndromes, run by Cyclarity Therapeutics, Inc. at 3 sites in Australia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease, Acute Coronary Syndromes
- What is being tested?
- UDP-003
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 3 sitesAustralia
- Study dates
- 25 Feb 2025to 30 Dec 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All Participants:
- 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 Participants (SAD and MAD cohorts):
- 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.
Show all 13Show fewer
- 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).
- 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):
- 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).
- Adult males and females of body mass index (BMI) ≥ 18
- 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.
- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Australia3 sites, 3 recruiting
- Recruiting
CMAX Clinical Research
Adelaide, South Australia, 5000
Jane Kelly, +61(08)70887900, cmax@cmax.com.au
Sepehr Shakib, PhD
- Not yet recruiting
Emeritus Research Camberwell
Camberwell, Victoria, 3124
Sewa Rijal, Dr, +61 (03) 95096166, sewarijal@emeritusresearch.com
- Not yet recruiting
ACS Research Pty Ltd
Melbourne, Victoria, 3150
Adam Brown, Associate Professor, +61 (03) 9791 3811, Adam@auscardio.com.au
About this study
Official title: A Double Blind, Placebo-controlled Study in Healthy Participants to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of UDP-003 and Followed by an Open-label Multiple-dose Patient Cohort
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.
Read more
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.
Read the detailed description
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:
- Part 1: 6 cohorts of 6 healthy participants receiving SADs,
- Part 2: 3 cohorts of 12 healthy participants receiving MADs (6 doses over 16 days),
- Part 3: 1 cohort of 12 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 SAD part will include healthy participants randomised to either active or placebo with a 2:1 ratio (24 active, 12 placebo) and the MAD parts with a 3:1 ratio (27 active, 9 placebo), in addition to up to 12 MD patient cohort receiving UDP-003.
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.
- 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.
- Being tested
- UDP-003, Placebo
- Keywords
- Atherosclerosis, 7-ketocholesterol (7KC), Cyclodextrin, Plaque burden reduction, Healthy Participants, Acute coronary syndrome
- Medical subject headings
- Atherosclerosis, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UDP-003Drug
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.
PlaceboOther
Placebo will be provided as a sterile clear, colourless solution formulated to match viscosity of the UDP-003 solution.
| Study group | Role | What they receive |
|---|---|---|
| UDP-003 | Experimental | 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. Receives: Drug: UDP-003 |
| Placebo | Placebo comparator | 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety outcome measures (Adverse Events)
Occurrence of adverse events (AEs) of any type and severity
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: 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
Measured: 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)].
Measured: 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
Measured: 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])
Measured: 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
Measured: 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
Measured: From enrolment through 24 hours post dose for SAD Participants (Day 2), 24 hours post dose for MAD and MD Patients Participants (Day 17),
Secondary outcomes (6)
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
Measured: 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
Measured: 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%).
Measured: 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
Measured: 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
Measured: 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
Measured: Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start25 Feb 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cyclarity Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Monash University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06813339
- Sponsor's protocol ID
- CTx-001
- Acronym
- CTx-001
- Status last verified
- Jun 2026
- First submitted
- 13 Jan 2025
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo-controlled Study in Healthy Participants to Investigate the Safety, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of UDP-003 and Followed by an Open-label Multiple-dose Patient Cohort
- ClinicalTrials.gov ID
- NCT06813339
- Acronym / sponsor ID
- CTx-001 / CTx-001
- Keywords
- Atherosclerosis, 7-ketocholesterol (7KC), Cyclodextrin, Plaque burden reduction, Healthy Participants, Acute coronary syndrome
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cyclarity Therapeutics, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Monash University
- Study start
- 25 Feb 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Part 1: 6 cohorts of 6 healthy participants receiving SADs,
- Part 2: 3 cohorts of 12 healthy participants receiving MADs (6 doses over 16 days),
- Part 3: 1 cohort of 12 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 SAD part will include healthy participants randomised to either active or placebo with a 2:1 ratio (24 active, 12 placebo) and the MAD parts with a 3:1 ratio (27 active, 9 placebo), in addition to up to 12 MD patient cohort receiving UDP-003.
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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UDP-003 | Experimental | Drug: UDP-003UDP-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. |
| Placebo | Placebo comparator | Other: PlaceboPlacebo 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. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UDP-003The 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. | Drug | UDP-003 |
| PlaceboPlacebo will be provided as a sterile clear, colourless solution formulated to match viscosity of the UDP-003 solution. | Other | Placebo |
Primary outcome
Safety outcome measures (Adverse Events)
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Occurrence of adverse events (AEs) of any type and severity
Safety outcome measures (Vital Signs: Systolic Blood Pressure)
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
SBP will be measured in mmHg
Safety outcome measures (Vital Signs: Diastolic Blood Pressure)
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
DBP will be measured in mmHg
Safety outcome measures (Vital signs: Heart Rate)
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Heart Rate will be measured in bpm
Safety outcome measures (Vital signs: Respiratory Rate)
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
RR will be measured in rpm
Safety outcome measures (Vital signs: Temperature)
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
Body temperature will be measured in Celsius (0C)
Safety outcome measures (Clinical Laboratory Parameters)
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
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
Safety outcome measures (ECG QTCF Interval)
Time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients
The QTcF interval will be calculated using the formula QTcF = QT/√R-R interval in seconds
Safety outcome measures (Injection site reactions)
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
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)].
Safety outcome measures (Audiometry: PTA)
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),
Air/Bone Pure-tone audiometry (PTA) conduction testing will be done at 250, 500, 1000, 3000, 4000, 6000 and 8000Hz
Safety outcome measures (Audiometry: HFA)
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),
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])
Safety outcome measures (Audiometry: Self-evaluation questionnaire (THI))
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),
Self-evaluation questionnaire: using Tinnitus Handicap Inventory [THI] questionnaire
Safety outcome measures (Audiometry: Self-evaluation questionnaire (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),
Self-evaluation questionnaire: using Dizziness Handicap Inventory [DHI] questionnaire
6 secondary outcomes
Pharmacokinetics Outcome Measures (Cmax)
Time frame: Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Pharmacokinetics Outcome Measures (Tmax)
Time frame: Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Pharmacokinetics Outcome Measures (half-life (t1/2))
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)
Time frame: Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Pharmacokinetics Outcome Measures (Total Plasma Clearance (CL))
Time frame: Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Pharmacokinetics Outcome Measures (Volume of Distribution (Vd))
Time frame: Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing UDP-003 in people with Atherosclerotic Cardiovascular Disease and Acute Coronary Syndromes, run by Cyclarity Therapeutics, Inc. at 3 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daniel M Clemens, Ph.D. ((707) 200-3610, info@cyclaritytx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety outcome measures (Adverse Events) (time frame: From enrolment through 4 weeks for SAD Participants, 6 weeks for MAD Participants and 28 weeks for MD Patients). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.