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Completed

NCT Number: NCT07033455

A Trial of HRS-1893 in Healthy Volunteers

The purpose of this study is to assess the safety and PK characteristics of a single oral dose of HRS-1893 in healthy voluunters.

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Key information

Conditions

Hypertrophic Cardiomyopathy Aortic Stenosis, Subvalvular Aortic Valve Disease Aortic Valve Stenosis Cardiomyopathies Cardiomyopathy, Hypertrophic Cardiovascular Diseases Heart Diseases Heart Valve Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

HRS-1893

Drug

Single dose of HRS-1893 orally administered

Primary outcomes

  1. PK profile of HRS-1893 after a single oral (PO) administration

    Time frame: Day 8

    Pharmacokinetics PK Cmax: Plasma Cmax

  2. PK profile of HRS-1893 after a single oral (PO) administration

    Time frame: Day 8

    Pharmacokinetics PK AUClast : Plasma AUClast

  3. PK profile of HRS-1893 after a single oral (PO) administration

    Time frame: Day 8

    Pharmacokinetics PK AUC0-inf: Plasma AUC0-inf

  4. PK profile of HRS-1893 after a single oral (PO) administration

    Time frame: Day 8

    Pharmacokinetics PK Tmax :Plasma Tmax

  5. PK profile of HRS-1893 after a single oral (PO) administration

    Time frame: Day 8

    Pharmacokinetics PK t1/2 : Plasma t1/2

  6. PK profile of HRS-1893 after a single oral (PO) administration

    Time frame: Day 8

    Pharmacokinetics PK CL/F: Plasma CL/F

  7. PK profile of HRS-1893 after a single oral (PO) administration

    Time frame: Day 8

    Pharmacokinetics PK Vz/F: Plasma Vz/F

  8. 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)

  9. 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)

  10. Renal clearance of HRS-1893 after a single oral administration

    Time frame: Day 8

    Renal clearance (CLr)

Secondary outcomes

  1. Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events

    Time frame: Day 8

    Number of participants with Adverse events and Serious adverse events

Sponsors and collaborators

Lead sponsor

Atridia Pty Ltd.

Industry

Registry information

Official study title

A Phase 1, Open-label Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of HRS-1893 in Healthy Participants

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 24, 2025
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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