A Phase I Clinical Study Evaluating the Safety, Tolerability, Pharmacokinetics and Food Effect on the Pharmacokinetics of HRS-9813 Tablets After Single and Multiple Ascending Oral Doses in Healthy Volunteers

Guangdong Hengrui Pharmaceutical Co., Ltd1 site in 1 country50 target enrollmentJuly 24, 2024

ConditionsHealthy Volunteers

InterventionsHRS-9813 Placebo

Overview

Phase: Phase 1
Intervention: HRS-9813
Conditions: Healthy Volunteers
Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Enrollment: 50
Locations: 1
Primary Endpoint: Safety: incidence of adverse event (AE), serious adverse event (SAE)
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this phase Ⅰ study is to evaluate the safety, tolerability and pharmacokinetics of HRS-9813 in healthy volunteers.

Registry

clinicaltrials.gov

Start Date

July 24, 2024

End Date

January 2, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Guangdong Hengrui Pharmaceutical Co., Ltd

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Understand the study procedures and methods, voluntarily participate in the study, comply with study requirements, and sign the written informed consent form (ICF);
•Male or female aged 18-55 (adult healthy volunteers);
•Body mass index (BMI) between 19 and 26 kg/m2;
•Normal Electrocardiogram (ECG);
•Men and women of childbearing potential must agree to take effective contraceptive methods.

Exclusion Criteria

•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;
•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;
•Seated systolic blood pressure (SBP) of \<90 mmHg or seated diastolic blood pressure (DBP) of \<60 mmHg;
•Patients with orthostatic hypotension;
•Positive results of hepatitis B surface antigen, hepatitis C antibody, syphilis antibody and human immunodeficiency virus antibody.

Arms & Interventions

single ascending dose (SAD) cohorts

Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-9813 or placebo

Intervention: HRS-9813

single ascending dose (SAD) cohorts

Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-9813 or placebo

Intervention: Placebo

multiple ascending dose (MAD) cohorts

Subjects will be assigned to one of 3-4 planned dose cohorts and receive multiple doses of HRS-9813 or placebo

Intervention: HRS-9813

multiple ascending dose (MAD) cohorts

Subjects will be assigned to one of 3-4 planned dose cohorts and receive multiple doses of HRS-9813 or placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Safety: incidence of adverse event (AE), serious adverse event (SAE)

Time Frame: 7 days (SAD), 14 days (MAD)

Secondary Outcomes

PK parameter of HRS-9813: Maximum Plasma Concentration (Cmax)(Days 1-9)
PK parameter of HRS-9813: Cumulative amount excreted (Ae) in the urine(Days 1-2)
PK parameter of HRS-9813: Half-life (t1/2)(Days 1-9)
PK parameter of HRS-9813: Renal clearance (CLR)(Days 1-2)
PK parameter of HRS-9813: Time to maximum plasma concentration (Tmax)(Days 1-9)
PK parameter of HRS-9813: Apparent volume of distribution (Vz/F)(Days 1-9)
PK parameter of HRS-9813: Fractional excretion (fe) in the urine(Days 1-2)
PK parameter of HRS-9813: Area under the concentration time curve (AUC)(Days 1-9)
PK parameter of HRS-9813: Apparent clearance (CL/F)(Days 1-9)
PK parameter of HRS-9813: Accumulation ratio (Racc)(Days 1-9)