A Trial of HRS-9813 in Healthy Volunteers

NCT06514963 | Completed Phase 1

• 1 other identifier: HRS-9813-101
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

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

  7 days (SAD), 14 days (MAD)

Secondary Outcomes (10)

• 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

Study Arms (2)

single ascending dose (SAD) cohorts

EXPERIMENTAL

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

Drug: HRS-9813; Drug: Placebo

multiple ascending dose (MAD) cohorts

EXPERIMENTAL

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

Drug: HRS-9813; Drug: Placebo

Interventions

HRS-9813 DRUG

Specified dose on specified days

multiple ascending dose (MAD) cohorts; single ascending dose (SAD) cohorts

Placebo DRUG

Specified dose on specified days

multiple ascending dose (MAD) cohorts; single ascending dose (SAD) cohorts

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Guangdong Hengrui Pharmaceutical Co., Ltd: lead

Study Sites (1)

Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: HRS-9813 compared with placebo

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: July 24, 2024
• Primary Completion: January 2, 2025
• Study Completion: January 2, 2025
• Last Updated: January 8, 2025

Record last verified: 2024-07

Locations

CN (1)