A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ，Pharmacodynamics of Oral SHR2150 in Healthy Subjects

HIV-1 Infection Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04802811
• Other study ID #: SHR2150-I-103
• Status: Completed
• Phase: Phase 1
• Start date: March 22, 2021
• Est. completion date: November 10, 2021

Study information

• Verified date: March 2021
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: November 10, 2021
• Est. primary completion date: November 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1 Infection

Intervention

Drug:
• SHR2150;Placebo
Single dose;SHR2150-dose 1 or Placebo-dose 1
• SHR2150;Placebo
Single dose;SHR2150-dose 2 or Placebo-dose 2
• SHR2150;Placebo
Single dose;SHR2150-dose 3 or Placebo-dose 3
• SHR2150;Placebo
Single dose;SHR2150-dose 4 or Placebo-dose 4
• SHR2150;Placebo
Single dose;SHR2150-dose 5 or Placebo-dose 5

Locations

Country	Name	City	State
China	Beijing youan Hospital,Capital medical university	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma :[AUC0-last]	The area under the concentration-time curve from time zero (pre-dose) to last time.	Up to 96hours
Secondary	Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [AUC0-8]	The area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.	Up to 96hours
Secondary	Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma :[t1/2]	Terminal Half-life	Up to 96hours
Secondary	Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma: [Tmax]	Time to Maximum Observed Concentration	Up to 96hours
Secondary	Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [Cmax]	Maximum Observed Plasma Concentration	Up to 96hours
Secondary	Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [CL/F]	Apparent clearance	Up to 96hours
Secondary	Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [Vz/F]	Apparent volume of distribution	Up to 96hours
Secondary	Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma : [MRT]	Mean retention time	Up to 96hours
Secondary	Pharmacodynamics: Changes in Cytokines in Serum: interferon ?-inducible protein-10		Up to 48hhours
Secondary	Pharmacodynamics: Changes in Cytokines in Serum: Interferon-a		Up to 48hours