A Trial of HRS-1893 in Healthy Volunteers

Phase 1

Recruiting

• Conditions: Hypertrophic Cardiomyopathy
• Interventions: Drug: HRS-1893

• Registration Number: NCT07033455
• Lead Sponsor: Atridia Pty Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-20
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-13
• Study First Posted: 2025-06-24
• Study Start: 2025-06-25
• Last Update Submitted: 2025-06-25
• Last Update Posted: 2025-06-29
• Primary Completion: 2025-09-30
• Study Completion: 2025-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
HRS-1893 Dose level 1	HRS-1893	Single oral low dose of HRS-1893 (dose level 1)
HRS-1893 Dose level 2	HRS-1893	Single oral high dose of HRS-1893 (dose level 2)

Primary Outcome Measures

Name	Time	Method
PK profile of HRS-1893 after a single oral (PO) administration	Day 8	Pharmacokinetics PK Vz/F: Plasma Vz/F
Cumulative amount of drug excreted in urine of HRS-1893 after a single oral administration	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:	Day 8	Cumulative percentage of dose recovered in urine (%Ae,ur)
Renal clearance of HRS-1893 after a single oral administration	Day 8	Renal clearance (CLr)

Secondary Outcome Measures

Name	Time	Method
Safety and Tolerability Based on Incidence and Severity of Treatment Emergent Adverse Events	Day 8	Number of participants with Adverse events and Serious adverse events

Trial Locations

Locations (1)

Linear Clinical Research; 🇦🇺 Nedlands, Western Australia, Australia