Actively Recruiting
A Trial of HRS-9813 in Healthy Subjects
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-05-07
60
Participants Needed
1
Research Sites
19 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety and pharmacokinetics of HRS-9813 after multiple oral administration in healthy subjects.
CONDITIONS
Official Title
A Trial of HRS-9813 in Healthy Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily sign informed consent and understand the trial procedures and risks
- Aged 18 to 45 years, healthy male or female
- Male weight at least 50 kg, female weight at least 45 kg, BMI between 19 and 26 kg/m2
- Normal or clinically insignificant results in physical exams, vital signs, ECG, chest X-rays, abdominal ultrasound, and labs
- Use contraception starting 2 weeks before consent and through follow-up; no plans to have children or donate sperm/eggs during the trial
You will not qualify if you...
- History or presence of serious diseases affecting various body systems or conditions that may interfere with trial results
- History of malignant tumors except certain cured or removed types
- Conditions affecting drug absorption, metabolism, or excretion
- Severe infection, trauma, or major surgery within 3 months before screening or planned surgery during trial
- Use of any drugs within 2 weeks before screening or planned use during trial, except occasional acetaminophen and vitamins
- Participation in other clinical trials within 3 months or planned participation during study
- Abnormal blood pressure (systolic <90 mmHg or diastolic <60 mmHg) or orthostatic hypotension at screening
- Clinically significant abnormal ECG results including prolonged QTcB
- Elevated serum creatinine or reduced kidney function (eGFR <70 mL/min/1.73m2)
- Liver enzyme elevations or bilirubin exceeding specified limits
- Positive tests for hepatitis B, HIV, syphilis, or hepatitis C
- Pregnant or lactating women or positive pregnancy test
- Recent severe blood loss, blood transfusion, or plans to donate blood
- Recent vaccination or plan to vaccinate during trial
- Smoking more than 5 cigarettes daily within 4 weeks or inability to stop tobacco use
- Excessive alcohol intake or positive alcohol breath test
- History of drug abuse or positive drug test
- Excessive caffeine intake within 6 months
- Consumption of special foods or beverages within 48 hours before baseline
- Special dietary needs incompatible with study diet
- Difficulty swallowing or undergoing blood collection
- Any other condition deemed unsuitable by investigators
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Shanghai General Hospital
Shanghai, Shanghai Municipality, China, 200080
Actively Recruiting
Research Team
R
Ruifang Guan
CONTACT
S
Sheng Feng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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