RECRUITING Early Phase 1 ClinicalTrials.gov

Placebo-controlled Study of Single and Multiple Ascending Doses of UDP-003 in Healthy Human Participants and Followed by an Open-label Patient Cohort

Sponsor: Cyclarity Therapeutics, Inc. • ClinicalTrials.gov ID: NCT06813339

Registry updated: 2026-09-25

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Description

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.

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

Eligibility criteria

Inclusion Criteria All Participants: 1. Participant understands study procedures and provides written informed consent for the trial. 2. Participant is able to comply with the protocol and the assessments therein. Healthy Participants (SAD and MAD cohorts): 1. Healthy adult males and females, 18 to 65 years of age (inclusive) at the time of screening. 2. Adult males and females of body mass index (BMI) ≥ 18 and ≤ 32 kg/m² and body weight ≥ 50 and ≤ 120 kg. 3. 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). 4. 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): 1. 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). 2. Adult males and females of body mass index (BMI) ≥ 18 3. 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. 4. 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.

Conditions

Atherosclerotic Cardiovascular Disease Acute Coronary Syndromes

Locations

CMAX Clinical Research — Adelaide, South Australia, Australia
Emeritus Research Camberwell — Camberwell, Victoria, Australia
ACS Research Pty Ltd — Melbourne, Victoria, Australia

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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