Hypertrophic CardiomyopathyEarly Phase 1NCT07033455
A Trial of HRS-1893 in Healthy Volunteers
A Early Phase 1 study testing HRS-1893 in people with Hypertrophic Cardiomyopathy, run by Atridia Pty Ltd. at 1 site in Australia.
Trial summary
The purpose of this study is to assess the safety and PK characteristics of a single oral dose of HRS-1893 in healthy voluunters. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertrophic Cardiomyopathy
- What is being tested?
- HRS-1893
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 25 Jun 2025to 30 Oct 2025
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy white participants;
- Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
- Male aged between 18 to 55 years of age (inclusive)
- Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive) at screening.
- Negative pregnancy test for women of childbearing potential (WOCBP) at baseline. Men and WOCBP must agree to take highly effective contraceptive methods
Who cannot join
- History or evidence of clinically significant disorders
- History of cardiomyopathy and/or unexplained heart failure
- Individuals with a history of drug allergies, specific allergies
- Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of HRS-1893 in Healthy Participants
The purpose of this study is to assess the safety and PK characteristics of a single oral dose of HRS-1893 in healthy voluunters.
- Conditions
- Hypertrophic Cardiomyopathy
- Being tested
- HRS-1893
- Medical subject headings
- Cardiomyopathy, Hypertrophic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRS-1893Drug
Single dose of HRS-1893 orally administered
| Study group | Role | What they receive |
|---|---|---|
| HRS-1893 Dose level 1 | Experimental | Single oral low dose of HRS-1893 (dose level 1) Receives: Drug: HRS-1893 |
| HRS-1893 Dose level 2 | Experimental | Single oral high dose of HRS-1893 (dose level 2) Receives: Drug: HRS-1893 |
What is being measured
The primary outcome is the main question the study is designed to answer.
PK profile of HRS-1893 after a single oral (PO) administration
Pharmacokinetics PK Cmax: Plasma Cmax
Measured: Day 8
PK profile of HRS-1893 after a single oral (PO) administration
Pharmacokinetics PK AUClast : Plasma AUClast
Measured: Day 8
PK profile of HRS-1893 after a single oral (PO) administration
Pharmacokinetics PK AUC0-inf: Plasma AUC0-inf
Measured: Day 8
PK profile of HRS-1893 after a single oral (PO) administration
Pharmacokinetics PK Tmax :Plasma Tmax
Measured: Day 8
PK profile of HRS-1893 after a single oral (PO) administration
Pharmacokinetics PK t1/2 : Plasma t1/2
Measured: Day 8
PK profile of HRS-1893 after a single oral (PO) administration
Pharmacokinetics PK CL/F: Plasma CL/F
Measured: Day 8
PK profile of HRS-1893 after a single oral (PO) administration
Pharmacokinetics PK Vz/F: Plasma Vz/F
Measured: Day 8
Cumulative amount of drug excreted in urine of HRS-1893 after a single oral administration
Cumulative amount of drug excreted in urine (Ae,ur)
Measured: Day 8
Cumulative percentage of dose recovered in urine of HRS-1893 after a single oral administration:
Cumulative percentage of dose recovered in urine (%Ae,ur)
Measured: Day 8
Renal clearance of HRS-1893 after a single oral administration
Renal clearance (CLr)
Measured: Day 8
Secondary outcomes (1)
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Number of participants with Adverse events and Serious adverse events
Measured: Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2025
- Study start25 Jun 2025
- Primary completion5 Sep 2025
- Study completion30 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertrophic CardiomyopathyStudies 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
- Non-randomised
- Intervention model
- Sequential
- Model description
- HRS-1893 Oral dosage only
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atridia Pty Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07033455
- Sponsor's protocol ID
- HRS-1893-105
- Status last verified
- Jun 2025
- First submitted
- 20 May 2025
- Last updated
- 18 Nov 2025
- 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 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of HRS-1893 in Healthy Participants
- ClinicalTrials.gov ID
- NCT07033455
- Acronym / sponsor ID
- HRS-1893-105
- Conditions
- Hypertrophic Cardiomyopathy
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Atridia Pty Ltd.Industry (pharma, biotech, devices)
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 30 Oct 2025 (actual)
- First posted
- 24 Jun 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 purpose of this study is to assess the safety and PK characteristics of a single oral dose of HRS-1893 in healthy voluunters.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- HRS-1893 Oral dosage only
| Arm | Type | Receives |
|---|---|---|
| HRS-1893 Dose level 1 | Experimental | Drug: HRS-1893Single oral low dose of HRS-1893 (dose level 1) |
| HRS-1893 Dose level 2 | Experimental | Drug: HRS-1893Single oral high dose of HRS-1893 (dose level 2) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy white participants;
- Ability to understand the trial procedures and possible adverse events, volunteer to participate in the trial, and provide written informed consent, be able to comply with all the requirements, and able to complete the study.
- Male aged between 18 to 55 years of age (inclusive)
- Women with body weight ≥ 45.0 kg, men with body weight ≥ 50.0 kg, body mass index (BMI) between 19.0 and 30.0 kg/m2 (inclusive) at screening.
- Negative pregnancy test for women of childbearing potential (WOCBP) at baseline. Men and WOCBP must agree to take highly effective contraceptive methods
Key exclusion criteria (4 listed)
- History or evidence of clinically significant disorders
- History of cardiomyopathy and/or unexplained heart failure
- Individuals with a history of drug allergies, specific allergies
- Any other circumstances (e.g., not suitable for venous access) or laboratory abnormality that, in the investigator's judgment, may increase the risk to the participant, or be associated with the participant's participation in and completion of the study or could preclude the evaluation of the participant's response.
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 |
|---|---|---|
| HRS-1893Single dose of HRS-1893 orally administered | Drug | HRS-1893 Dose level 1, HRS-1893 Dose level 2 |
Primary outcome
PK profile of HRS-1893 after a single oral (PO) administration
Time frame: Day 8
Pharmacokinetics PK Cmax: Plasma Cmax
PK profile of HRS-1893 after a single oral (PO) administration
Time frame: Day 8
Pharmacokinetics PK AUClast : Plasma AUClast
PK profile of HRS-1893 after a single oral (PO) administration
Time frame: Day 8
Pharmacokinetics PK AUC0-inf: Plasma AUC0-inf
PK profile of HRS-1893 after a single oral (PO) administration
Time frame: Day 8
Pharmacokinetics PK Tmax :Plasma Tmax
PK profile of HRS-1893 after a single oral (PO) administration
Time frame: Day 8
Pharmacokinetics PK t1/2 : Plasma t1/2
PK profile of HRS-1893 after a single oral (PO) administration
Time frame: Day 8
Pharmacokinetics PK CL/F: Plasma CL/F
PK profile of HRS-1893 after a single oral (PO) administration
Time frame: Day 8
Pharmacokinetics PK Vz/F: Plasma Vz/F
Cumulative amount of drug excreted in urine of HRS-1893 after a single oral administration
Time frame: Day 8
Cumulative amount of drug excreted in urine (Ae,ur)
Cumulative percentage of dose recovered in urine of HRS-1893 after a single oral administration:
Time frame: Day 8
Cumulative percentage of dose recovered in urine (%Ae,ur)
Renal clearance of HRS-1893 after a single oral administration
Time frame: Day 8
Renal clearance (CLr)
1 secondary outcome
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events
Time frame: Day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Related trials for Hypertrophic Cardiomyopathy
Not yet recruiting
Human Experimental Models of Pain (HEMP)
Acute Pain
Not yet recruiting
NHLBI SESAME (SEptal Scoring Along Midline Endocardium) Multi-Center Prospective Study Using Improvised Off-Label Devices
Hypertrophic Cardiomyopathy, Left Ventricular Outflow Obstruction
RecruitingPhase 1
Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HTX-001
Nonobstructive Hypertrophic Cardiomyopathy
Recruiting
Positron Emission Tomography to Assess the Effect of Camzyos on Ischaemia in HOCM: PEACH Trial
Hypertrophic Obstructive Cardiomyopathy \(HOCM\), Left Ventricular Outflow Tract Obstruction
RecruitingObservational study
A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease
Coronary Artery Disease, Myocarditis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 HRS-1893 in people with Hypertrophic Cardiomyopathy, run by Atridia Pty Ltd. at 1 site 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 5 inclusion and 4 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: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PK profile of HRS-1893 after a single oral (PO) administration (time frame: Day 8). The study lists 10 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 18 Nov 2025.