A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ，Pharmacodynamics of Oral SHR2150 in Healthy Subjects
Phase 1
Completed
- Conditions
- HIV-1 Infection
- Interventions
- Drug: SHR2150；Placebo
- Registration Number
- NCT04802811
- Lead Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 37
Inclusion Criteria
- 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 Criteria
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Treatment group D SHR2150；Placebo - Treatment group A SHR2150；Placebo - Treatment group B SHR2150；Placebo - Treatment group C SHR2150；Placebo - Treatment group E SHR2150；Placebo -
- Primary Outcome Measures
Name Time Method The incidence and severity of treatment-related adverse events as assessed by CTCAE v5.0. 9 DAYS for Group A.B.C.D.E
- Secondary Outcome Measures
Name Time Method Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [Cmax] Up to 96hours Maximum Observed Plasma Concentration
Pharmacodynamics: Changes in Cytokines in Serum: Interferon-α Up to 48hours Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ：[t1/2] Up to 96hours Terminal Half-life
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [CL/F] Up to 96hours Apparent clearance
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ：[AUC0-last] Up to 96hours The area under the concentration-time curve from time zero (pre-dose) to last time.
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [AUC0-∞] Up to 96hours The area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [Vz/F] Up to 96hours Apparent volume of distribution
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma： [Tmax] Up to 96hours Time to Maximum Observed Concentration
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [MRT] Up to 96hours Mean retention time
Pharmacodynamics: Changes in Cytokines in Serum: interferon γ-inducible protein-10 Up to 48hhours
Trial Locations
- Locations (1)
Beijing youan Hospital,Capital medical university
🇨🇳Beijing, Beijing, China