A Trial of HRS-1893 in Healthy Volunteers

NCT ID: NCT07033455

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-06-25
• Study Completion Date: 2025-10-30

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HRS-1893 Dose level 1

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

Group Type: EXPERIMENTAL

HRS-1893

Intervention Type: DRUG

Single dose of HRS-1893 orally administered

HRS-1893 Dose level 2

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

Group Type: EXPERIMENTAL

HRS-1893

Intervention Type: DRUG

Single dose of HRS-1893 orally administered

Interventions

HRS-1893

Single dose of HRS-1893 orally administered

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Healthy white participants;

2. 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.

3. Male aged between 18 to 55 years of age (inclusive)

4. 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.

5. Negative pregnancy test for women of childbearing potential (WOCBP) at baseline. Men and WOCBP must agree to take highly effective contraceptive methods

Exclusion Criteria

1. History or evidence of clinically significant disorders

2. History of cardiomyopathy and/or unexplained heart failure

3. Individuals with a history of drug allergies, specific allergies

4. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atridia Pty Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Linear Clinical Research

Nedlands, Western Australia, Australia

Countries

Australia

Other Identifiers

HRS-1893-105

Identifier Type: -

Identifier Source: org_study_id