A Trial of HRS-1893 in Healthy Volunteers

Atridia

Status and phase: Completed; Early Phase 1

Conditions: Hypertrophic Cardiomyopathy

Treatments: Drug: HRS-1893

Study type: Interventional

Funder types: Industry

Identifiers

NCT07033455

HRS-1893-105

Details and patient eligibility

About

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

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

HRS-1893 Dose level 1

Experimental group

Description:

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

Treatment:

Drug: HRS-1893

HRS-1893 Dose level 2

Experimental group

Description:

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

Treatment:

Drug: HRS-1893