Clinical trial NCT04802811: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ，Pharmacodynamics of Oral SHR2150 in Healthy Subjects
Official title: A Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics, Pharmacodynamics of Oral SHR2150 in Healthy Subjects With Single Dose of SHR2150 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV-1 Infection
Lead sponsor: Jiangsu HengRui Medicine Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-17
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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. The purpose of this part is to explore the safety, tolerability ,pharmacokinetics and pharmacodynamics of single doses of SHR2150 capsule in healthy subjects.


Eligibility criteria: Inclusion Criteria:

1. Signed informed consent.
2. Aged 18\~45.
3. Body weight ≥ 50 kg for male; ≥ 45 kg for female, body mass index (BMI) between 18 to 28 kg/m2 ( Including boundary value) .
4. Vital signs, physical examination, laboratory results are within normal range or considered not clinically significant.
5. Female subjects (including partner) of childbearing potential must be using a medically acceptable form of birth control.

Exclusion Criteria:

1. Currently suffering from cardiovascular, liver, kidney, digestive, nervous, blood, thyroid or mental diseases.
2. 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..
3. 12-ECG test have clinical significant abnormality or the QT interval (QTc) \> 450 ms(male)/QTc)\> 460 ms(male) or\<300ms(female).
4. Screening for infectious diseases is positive (Including HBsAg, Anti-HCV, TPPA, Anti-HIV)
5. Suspected allergy to any ingredient in the study drug.
6. Have any drug that inhibits or induces liver metabolism within 1 month.
7. Any condition or disease that affects the absorption, metabolism, and/or excretion of the study drug judged by the investigator;
8. Treatment with immunosuppressant or interferon-containing drugs within 6 months of study drug administration;
9. Participated in clinical trials of any drug or medical device within 3 months before screening, or within 5 half-lives before screening;
10. Treatment with live(attenuated) vaccine within 2 months before taking the study drug or during the study or within 1 months after administration;
11. 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;
12. 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);
13. 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;
14. History of drug abuse , drug dependence or drug screening test is positive;
15. Pregnant or lactating women;
16. Other conditions that the investigator believes the subject is not suitable.

Primary outcomes:
measure: The incidence and severity of treatment-related adverse events as assessed by CTCAE v5.0.
timeFrame: 9 DAYS for Group A.B.C.D.E
Secondary outcomes:
measure: Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ：[AUC0-last]
timeFrame: Up to 96hours
measure: Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [AUC0-∞]
timeFrame: Up to 96hours
measure: Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ：[t1/2]
timeFrame: Up to 96hours
measure: Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma： [Tmax]
timeFrame: Up to 96hours
measure: Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [Cmax]
timeFrame: Up to 96hours
measure: Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [CL/F]
timeFrame: Up to 96hours
measure: Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [Vz/F]
timeFrame: Up to 96hours
measure: Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [MRT]
timeFrame: Up to 96hours
measure: Pharmacodynamics: Changes in Cytokines in Serum: interferon γ-inducible protein-10
timeFrame: Up to 48hhours
measure: Pharmacodynamics: Changes in Cytokines in Serum: Interferon-α
timeFrame: Up to 48hours
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing youan Hospital,Capital medical university
state: Beijing
Study officials:
References: