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

NCT ID: NCT04802811

Last Updated: 2021-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-22
• Study Completion Date: 2021-11-10

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.

Conditions

HIV-1 Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Treatment group A

Group Type: EXPERIMENTAL

SHR2150；Placebo

Intervention Type: DRUG

Single dose；SHR2150-dose 1 or Placebo-dose 1

Treatment group B

Group Type: EXPERIMENTAL

SHR2150；Placebo

Intervention Type: DRUG

Single dose；SHR2150-dose 2 or Placebo-dose 2

Treatment group C

Group Type: EXPERIMENTAL

SHR2150；Placebo

Intervention Type: DRUG

Single dose；SHR2150-dose 3 or Placebo-dose 3

Treatment group D

Group Type: EXPERIMENTAL

SHR2150；Placebo

Intervention Type: DRUG

Single dose；SHR2150-dose 4 or Placebo-dose 4

Treatment group E

Group Type: EXPERIMENTAL

SHR2150；Placebo

Intervention Type: DRUG

Single dose；SHR2150-dose 5 or Placebo-dose 5

Interventions

SHR2150；Placebo

Single dose；SHR2150-dose 1 or Placebo-dose 1

Intervention Type: DRUG

SHR2150；Placebo

Single dose；SHR2150-dose 2 or Placebo-dose 2

Intervention Type: DRUG

SHR2150；Placebo

Single dose；SHR2150-dose 3 or Placebo-dose 3

Intervention Type: DRUG

SHR2150；Placebo

Single dose；SHR2150-dose 4 or Placebo-dose 4

Intervention Type: DRUG

SHR2150；Placebo

Single dose；SHR2150-dose 5 or Placebo-dose 5

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Beijing youan Hospital,Capital medical university

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

SHR2150-I-103

Identifier Type: -

Identifier Source: org_study_id