A Trial of HRS-1893 in Healthy Volunteers

NCT07033455 | Completed Early Phase 1 DMC

• 1 other identifier: HRS-1893-105
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hypertrophic Cardiomyopathy

Outcome Measures

Primary Outcomes (10)

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

  Pharmacokinetics PK Cmax: Plasma Cmax

  Day 8

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

  Pharmacokinetics PK AUClast : Plasma AUClast

  Day 8

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

  Pharmacokinetics PK AUC0-inf: Plasma AUC0-inf

  Day 8

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

  Pharmacokinetics PK Tmax :Plasma Tmax

  Day 8

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

  Pharmacokinetics PK t1/2 : Plasma t1/2

  Day 8

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

  Pharmacokinetics PK CL/F: Plasma CL/F

  Day 8

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

  Pharmacokinetics PK Vz/F: Plasma Vz/F

  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)

  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)

  Day 8

• Renal clearance of HRS-1893 after a single oral administration

  Renal clearance (CLr)

  Day 8

Secondary Outcomes (1)

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

  Day 8

Study Arms (2)

HRS-1893 Dose level 1

EXPERIMENTAL

Single oral low dose of HRS-1893 (dose level 1)

Drug: HRS-1893

HRS-1893 Dose level 2

EXPERIMENTAL

Single oral high dose of HRS-1893 (dose level 2)

Drug: HRS-1893

Interventions

HRS-1893 DRUG

Single dose of HRS-1893 orally administered

HRS-1893 Dose level 1; HRS-1893 Dose level 2

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Atridia Pty Ltd.: lead

Study Sites (1)

Linear Clinical Research

Nedlands, Western Australia, 6009, Australia

Location

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS-1893 Oral dosage only

Study Record Dates

• First Submitted: May 20, 2025
• First Posted: June 24, 2025
• Study Start: June 25, 2025
• Primary Completion: September 5, 2025
• Study Completion: October 30, 2025
• Last Updated: November 18, 2025

Record last verified: 2025-06

Locations

AU (1)