Status:
COMPLETED
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ，Pharmacodynamics of Oral SHR2150 in Healthy Subjects
Lead Sponsor:
Jiangsu HengRui Medicine Co., Ltd.
Conditions:
HIV-1 Infection
Eligibility:
All Genders
18-45 years
Phase:
PHASE1
Brief Summary
The study is a randomized, Double-Blind, Placebo-Controlled study to evaluate the safety, tolerability and pharmacokinetics, pharmacodynamics of SHR2150. will consist of 50 healthy subjects, 5 groups...
Eligibility Criteria
Inclusion
- Signed informed consent.
- Aged 18\~45.
- Body weight ≥ 50 kg for male; ≥ 45 kg for female, body mass index (BMI) between 18 to 28 kg/m2 ( Including boundary value) .
- Vital signs, physical examination, laboratory results are within normal range or considered not clinically significant.
- Female subjects (including partner) of childbearing potential must be using a medically acceptable form of birth control.
Exclusion
- Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
- Have severe infection, severe trauma or major surgical operations within 3 months. Plan to receive surgery during the trial and within two weeks after the end of the trial..
- 12-ECG test have clinical significant abnormality or the QT interval (QTc) \> 450 ms(male)/QTc)\> 460 ms(male) or\<300ms(female).
- Screening for infectious diseases is positive (Including HBsAg, Anti-HCV, TPPA, Anti-HIV)
- Suspected allergy to any ingredient in the study drug.
- Have any drug that inhibits or induces liver metabolism within 1 month.
- Any condition or disease that affects the absorption, metabolism, and/or excretion of the study drug judged by the investigator;
- Treatment with immunosuppressant or interferon-containing drugs within 6 months of study drug administration;
- Participated in clinical trials of any drug or medical device within 3 months before screening, or within 5 half-lives before screening;
- Treatment with live(attenuated) vaccine within 2 months before taking the study drug or during the study or within 1 months after administration;
- Had donated blood or blood transfusion≥ 200 mL within 1 months before taking the study drug or had donated blood or blood transfusion≥ 400 mL within 3 months prior to screening;
- The average daily smoking ≥ 5 cigarettes within three months; the average daily alcohol intake in a month exceeds 15 g (15 g alcohol is equivalent to 450 mL beer or 150 mL wine or 50 mL low-alcohol);
- Keep smoking, drinking alcohol or consuming caffeinated foods or beverages (more than 8 cups, 1 cup = 250 mL) 2 days before taking the study drug and during the study; and those who have special dietary requirements and cannot follow the unified diet;
- History of drug abuse , drug dependence or drug screening test is positive;
- Pregnant or lactating women;
- Other conditions that the investigator believes the subject is not suitable.
Key Trial Info
Start Date :
March 22 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04802811
Start Date
March 22 2021
End Date
November 10 2021
Last Update
December 28 2021
Active Locations (1)
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1
Beijing youan Hospital,Capital medical university
Beijing, Beijing Municipality, China, 10069