Hypertrophic Cardiomyopathy
Conditions
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.
Interventions
DRUGHRS-1893
Single dose of HRS-1893 orally administered
Sponsors
Atridia Pty Ltd.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
HRS-1893 Oral dosage only
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Renal clearance of HRS-1893 after a single oral administration | Day 8 | Renal clearance (CLr) |
| PK profile of HRS-1893 after a single oral (PO) administration | Day 8 | Pharmacokinetics PK Cmax: Plasma Cmax |
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Australia
Outcome results
None listed