A Trial of HRS-9813 in Healthy Volunteers

Phase 1

Completed

• Conditions: Healthy Volunteers
• Interventions: Drug: HRS-9813; Drug: Placebo

• Registration Number: NCT06514963
• Lead Sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-17
• Study First Submitted QC: 2024-07-17
• Study First Posted: 2024-07-23
• Study Start: 2024-07-24
• Primary Completion: 2025-01-02
• Study Completion: 2025-01-02
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
single ascending dose (SAD) cohorts	HRS-9813	Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-9813 or placebo
single ascending dose (SAD) cohorts	Placebo	Subjects will be assigned to one of 5 planned dose cohorts and receive single dose of HRS-9813 or placebo
multiple ascending dose (MAD) cohorts	HRS-9813	Subjects will be assigned to one of 3-4 planned dose cohorts and receive multiple doses of HRS-9813 or placebo
multiple ascending dose (MAD) cohorts	Placebo	Subjects will be assigned to one of 3-4 planned dose cohorts and receive multiple doses of HRS-9813 or placebo

Primary Outcome Measures

Name	Time	Method
Safety: incidence of adverse event (AE), serious adverse event (SAE)	7 days (SAD), 14 days (MAD)

Secondary Outcome Measures

Name	Time	Method
PK parameter of HRS-9813: Half-life (t1/2)	Days 1-9
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: 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

Trial Locations

Locations (1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China