Healthy Volunteers
Conditions
Brief summary
The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-9813 in healthy volunteers.
Interventions
DRUGHRS-9813
Specified dose on specified days
DRUGPlacebo
Specified dose on specified days
Sponsors
Guangdong Hengrui Pharmaceutical Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
HRS-9813 compared with placebo
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
1. Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF); 2. Male or female aged 18-55 (adult healthy volunteers); 3. Body mass index (BMI) between 19 and 26 kg/m2; 4. Normal Electrocardiogram (ECG); 5. Men and women of childbearing potential must agree to take effective contraceptive methods.
Exclusion criteria
1. Any significant acute or chronic medical condition that presents a potential risk to the participant and/or that may compromise the objectives of the study, including active, or history of, urinary stones, urinary tract infection, or intestinal disorder including irritable bowel syndrome; 2. History or presence of malignancy; participants with a history of basal cell or squamous cell carcinoma that has been treated with no evidence of recurrence within 5 years will be allowed for inclusion; 3. Seated systolic blood pressure (SBP) of \<90 mmHg or seated diastolic blood pressure (DBP) of \<60 mmHg; 4. Patients with orthostatic hypotension; 5. Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety: incidence of adverse event (AE), serious adverse event (SAE) | 7 days (SAD), 14 days (MAD) |
Secondary
| Measure | Time frame |
|---|---|
| PK parameter of HRS-9813: Maximum Plasma Concentration (Cmax) | Days 1-9 |
| PK parameter of HRS-9813: Time to maximum plasma concentration (Tmax) | Days 1-9 |
| PK parameter of HRS-9813: Half-life (t1/2) | Days 1-9 |
| PK parameter of HRS-9813: Apparent clearance (CL/F) | Days 1-9 |
| PK parameter of HRS-9813: Area under the concentration time curve (AUC) | Days 1-9 |
| PK parameter of HRS-9813: Accumulation ratio (Racc) | Days 1-9 |
| PK parameter of HRS-9813: Cumulative amount excreted (Ae) in the urine | Days 1-2 |
| PK parameter of HRS-9813: Fractional excretion (fe) in the urine | Days 1-2 |
| PK parameter of HRS-9813: Renal clearance (CLR) | Days 1-2 |
| PK parameter of HRS-9813: Apparent volume of distribution (Vz/F) | Days 1-9 |
Countries
China
Outcome results
None listed