A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ，Pharmacodynamics of Oral SHR2150 in Healthy Subjects
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Treatment group A
|
Drug: SHR2150；Placebo
Single dose；SHR2150-dose 1 or Placebo-dose 1
|
| Experimental: Treatment group B
|
Drug: SHR2150；Placebo
Single dose；SHR2150-dose 2 or Placebo-dose 2
|
| Experimental: Treatment group C
|
Drug: SHR2150；Placebo
Single dose；SHR2150-dose 3 or Placebo-dose 3
|
| Experimental: Treatment group D
|
Drug: SHR2150；Placebo
Single dose；SHR2150-dose 4 or Placebo-dose 4
|
| Experimental: Treatment group E
|
Drug: SHR2150；Placebo
Single dose；SHR2150-dose 5 or Placebo-dose 5
|
Outcome Measures
Primary Outcome Measures
- 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
- 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 ：[t1/2] [Up to 96hours]
Terminal Half-life
- 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 ： [Cmax] [Up to 96hours]
Maximum Observed Plasma Concentration
- 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 ： [Vz/F] [Up to 96hours]
Apparent volume of distribution
- 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]
- Pharmacodynamics: Changes in Cytokines in Serum: Interferon-α [Up to 48hours]
Eligibility Criteria
Criteria
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.
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Have any drug that inhibits or induces liver metabolism within 1 month.
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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;
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Other conditions that the investigator believes the subject is not suitable.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Beijing youan Hospital,Capital medical university | Beijing | Beijing | China | 10069 |
Sponsors and Collaborators
- Jiangsu HengRui Medicine Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHR2150-I-103