Actively Recruiting

Early Phase 1
Age: 18Years - 79Years
All Genders
Healthy Volunteers
NCT06813339

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

Led by Cyclarity Therapeutics, Inc. · Updated on 2026-02-24

84

Participants Needed

1

Research Sites

122 weeks

Total Duration

On this page

Sponsors

C

Cyclarity Therapeutics, Inc.

Lead Sponsor

M

Monash University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years - 79Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Healthy adult males and females aged 18 to 55 years for SAD and MAD cohorts
  • Medically healthy with normal renal tests and no significant abnormal screening results
  • Adult males and females aged 40 to 79 years diagnosed with acute coronary syndrome (NSTEMI or unstable angina) at least 12 months prior for patient cohort
  • Medically stable patients with no significant abnormal screening results
  • Patients on stable ACS treatment regimen for at least 3 months prior to screening with no planned changes during study participation
Not Eligible

You will not qualify if you...

  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric disease for healthy participants
  • History of myocardial infarction, transient ischemic attack, stroke, or family history of early coronary artery disease for healthy participants
  • Any clinically significant ECG abnormality at screening for healthy participants
  • Diabetic participants excluded from healthy cohorts
  • Planned percutaneous coronary intervention or angiogram after screening for patients
  • Post-MI pericarditis episode within 3 months before enrollment for patients
  • Ongoing heart failure classified as Class IV NYHA for patients
  • Significant disease in major organ systems for patients
  • Ongoing infection or febrile illness for patients
  • Ongoing atrial fibrillation or flutter for patients
  • History of MI, TIA, or stroke within 12 months prior to screening for patients
  • History or planned coronary artery bypass grafting for patients
  • Any cardiac intervention or hospitalization within past 12 months for patients
  • Clinically significant ECG abnormality at screening for patients
  • Contraindications to coronary CT angiography (CTA) for patients

AI-Screening

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Trial Site Locations

Total: 1 location

1

CMAX Clinical Research

Adelaide, South Australia, Australia, 5000

Actively Recruiting

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Research Team

D

Daniel M Clemens, Ph.D.

CONTACT

M

Matthew O'Connor, Ph.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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