A Trial of HRS-9813 in Healthy Volunteers

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: Placebo; Drug: HRS-9813

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Drug: Placebo; Specified dose on specified days; Drug: HRS-9813; Specified dose on specified days
Experimental: 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	Drug: Placebo; Specified dose on specified days; Drug: HRS-9813; Specified dose on specified days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Safety: incidence of adverse event (AE), serious adverse event (SAE)	7 days (SAD), 14 days (MAD)

Secondary Outcome Measures

Outcome Measure	Time Frame
PK parameter of HRS-9813: Area under the concentration time curve (AUC)	Days 1-9
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: Apparent volume of distribution (Vz/F)	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

Collaborators and Investigators

• Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): July 24, 2024
• Primary Completion (Actual): January 2, 2025
• Study Completion (Actual): January 2, 2025

Study Registration Dates

• First Submitted: July 17, 2024
• First Submitted That Met QC Criteria: July 17, 2024
• First Posted (Actual): July 23, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 6, 2025
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: HRS-9813-101

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No