Clinical trial NCT06514963: A Trial of HRS-9813 in Healthy Volunteers
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Lead sponsor: Guangdong Hengrui Pharmaceutical Co., Ltd
Sponsor class: INDUSTRY
First posted: 2024-07-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: HRS-9813 compared with placebo
Primary purpose: TREATMENT

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


Eligibility criteria: 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.

Primary outcomes:
measure: Safety: incidence of adverse event (AE), serious adverse event (SAE)
timeFrame: 7 days (SAD), 14 days (MAD)
Secondary outcomes:
measure: PK parameter of HRS-9813: Area under the concentration time curve (AUC)
timeFrame: Days 1-9
measure: PK parameter of HRS-9813: Maximum Plasma Concentration (Cmax)
timeFrame: Days 1-9
measure: PK parameter of HRS-9813: Time to maximum plasma concentration (Tmax)
timeFrame: Days 1-9
measure: PK parameter of HRS-9813: Half-life (t1/2)
timeFrame: Days 1-9
measure: PK parameter of HRS-9813: Apparent clearance (CL/F)
timeFrame: Days 1-9
measure: PK parameter of HRS-9813: Apparent volume of distribution (Vz/F)
timeFrame: Days 1-9
measure: PK parameter of HRS-9813: Accumulation ratio (Racc)
timeFrame: Days 1-9
measure: PK parameter of HRS-9813: Cumulative amount excreted (Ae) in the urine
timeFrame: Days 1-2
measure: PK parameter of HRS-9813: Fractional excretion (fe) in the urine
timeFrame: Days 1-2
measure: PK parameter of HRS-9813: Renal clearance (CLR)
timeFrame: Days 1-2
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology
state: Hubei
Study officials:
References: