Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Patients

NCT06813339 | Recruiting Early Phase 1 DMC

• 1 other identifier: CTx-001
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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 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 16 days). 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)
• 28 weeks 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.

Conditions

Acute Coronary Syndromes; Atherosclerotic Cardiovascular Disease

Keywords

Atherosclerosis; 7-ketocholesterol (7KC); Cyclodextrin; Plaque burden reduction; Healthy Participants; Acute coronary syndrome

Outcome Measures

Primary Outcomes (13)

• Safety outcome measures (Adverse Events)

  Occurrence of adverse events (AEs) of any type and severity

  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

  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

  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

  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

  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)

  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

  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

  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 \[Grade 1 (mild); Grade 2 (moderate); Grade 3 (severe) and Grade 4 (life threatening)\].

  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

  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 \[DHI\])

  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

  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

  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)

  Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts

• Pharmacokinetics Outcome Measures (Tmax)

  Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts

• Pharmacokinetics Outcome Measures (half-life (t1/2))

  Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts

• Pharmacokinetics Outcome Measures (AUC0-t and AUC0-inf)

  Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts

• Pharmacokinetics Outcome Measures (Total Plasma Clearance (CL))

  Day 1 for the SAD and Days 1 and 16 for the multiple dosing parts

Study Arms (2)

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.

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.

Other: Placebo

Interventions

UDP-003 DRUG

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.

UDP-003

Placebo OTHER

Placebo will be provided as a sterile clear, colourless solution formulated to match viscosity of the UDP-003 solution.

Placebo

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (Healthy Participants (SAD and MAD cohorts)):
• Healthy adult males and females, 18 to 55 years of age (inclusive) at the time of screening.
• 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).
• 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.

You may not qualify if:

• (Healthy Participants (SAD and MAD cohorts)):
• History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease as deemed by the Principal Investigator.
• History of myocardial infarction (MI), transient ischemic attack (TIA), stroke, or familial history of coronary artery disease or first-degree heart attack below the age of 60.
• Any clinically significant ECG abnormality at Screening
• Diabetic participants
• (Patients (MD cohort):
• Percutaneous coronary intervention or diagnostic angiogram planned after screening.
• Documented episode of post-MI pericarditis in the 3 months before enrollment.
• Ongoing heart failure as defined by Class IV New York Heart Association
• History or presence of significant pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease.
• Ongoing infection or febrile illness.
• Ongoing atrial fibrillation or flutter.
• History of MI, TIA, or stroke diagnosed within the 12 months prior to screening.
• History of or planned coronary artery bypass grafting.
• Any cardiac intervention or cardiac hospitalization in the past 12 months

Sponsors & Collaborators

• Cyclarity Therapeutics, Inc.: lead
• Monash University: collaborator

Study Sites (1)

CMAX Clinical Research

Adelaide, South Australia, 5000, Australia

RECRUITING

MeSH Terms

Conditions

Atherosclerosis; Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases

Central Study Contacts

Daniel M Clemens, Ph.D.

CONTACT

(707) 200-3610; info@cyclaritytx.com

Matthew O'Connor, Ph.D.

CONTACT

(707)200-3610; info@cyclaritytx.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: February 6, 2025
• Study Start: February 25, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): June 30, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

AU (1)