Early Phase 1 study for people with Heart Disease

Recruiting Early Phase 1

Sources: ClinicalTrials.gov Checked: 11 October 2026 Not medical advice

This trial at a glance

Status Recruiting
Phase Early Phase 1
Sponsor Cyclarity Therapeutics, Inc.
Registry number NCT06813339
Started 25 February 2025 Today 16 October 2026 Estimated completion 30 December 2026

Where this trial is running

Trial sites and the status recorded for each
SiteCityState or countryStatus at this site
CMAX Clinical Research Adelaide SA Recruiting
Emeritus Research Camberwell Camberwell VIC Not yet recruiting
ACS Research Pty Ltd Melbourne VIC Not yet recruiting

voxsanity.com.au · trial sites from public registries · registry record synced 11 October 2026 · not medical advice

Who can join

Age 18 Years to 79 Years
Sex Anyone, regardless of sex
Healthy volunteers Accepted
Enrolment target 84

The official eligibility criteria

Registry text, reproduced exactly. These are the words the trial's sponsor published on ClinicalTrials.gov. They have not been edited, shortened or rewritten, and they are written for researchers rather than for patients.

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.

Dates on the record

Started 25 February 2025
Estimated completion 30 December 2026
Registry last updated 25 September 2026
Checked by Voxsanity 11 October 2026

Results, publications and the official record

Sources and dates

  • ClinicalTrials.gov – the record this page reformats
  • ClinicalTrials.gov processing date: 25 September 2026.
  • This page last checked by Voxsanity: 11 October 2026.

Voxsanity reformats data from public registries into this layout. It does not edit, interpret or add to what the registry published.

Not medical advice.

Individual trial records are refreshed on a rolling basis rather than all at once, so a record may be up to several weeks old. Each trial page and trial card shows the date its own record was last synced. Where a record has lagged, its status, sites and enrolment can differ from the current registry state in either direction, so check the registry link on the trial page before acting on them.

Letter for your doctor

A one-page summary of this trial to print or email to your GP. It carries the registry's own record of the trial and its eligibility criteria, and nothing Voxsanity has written about whether it suits you.