A Trial of HRS-9813 in Healthy Volunteers

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Healthy Volunteers

Treatments: Drug: HRS-9813; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06514963

HRS-9813-101

Details and patient eligibility

About

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

Enrollment: 50 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

single ascending dose (SAD) cohorts

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: HRS-9813

multiple ascending dose (MAD) cohorts

Experimental group

Description:

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

Treatment:

Drug: Placebo

Drug: HRS-9813