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

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

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.

Study Overview

• Status: Completed
• Conditions: HIV-1 Infection
• Intervention / Treatment: Drug: SHR2150；Placebo; Drug: SHR2150；Placebo; Drug: SHR2150；Placebo; Drug: SHR2150；Placebo; Drug: SHR2150；Placebo

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 10069
      • Beijing youan hospital，capital medical university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treatment group A	Drug: SHR2150；Placebo; Single dose；SHR2150-dose 1 or Placebo-dose 1; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 2 or Placebo-dose 2; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 3 or Placebo-dose 3; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 4 or Placebo-dose 4; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 5 or Placebo-dose 5
EXPERIMENTAL: Treatment group B	Drug: SHR2150；Placebo; Single dose；SHR2150-dose 1 or Placebo-dose 1; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 2 or Placebo-dose 2; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 3 or Placebo-dose 3; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 4 or Placebo-dose 4; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 5 or Placebo-dose 5
EXPERIMENTAL: Treatment group C	Drug: SHR2150；Placebo; Single dose；SHR2150-dose 1 or Placebo-dose 1; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 2 or Placebo-dose 2; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 3 or Placebo-dose 3; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 4 or Placebo-dose 4; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 5 or Placebo-dose 5
EXPERIMENTAL: Treatment group D	Drug: SHR2150；Placebo; Single dose；SHR2150-dose 1 or Placebo-dose 1; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 2 or Placebo-dose 2; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 3 or Placebo-dose 3; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 4 or Placebo-dose 4; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 5 or Placebo-dose 5
EXPERIMENTAL: Treatment group E	Drug: SHR2150；Placebo; Single dose；SHR2150-dose 1 or Placebo-dose 1; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 2 or Placebo-dose 2; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 3 or Placebo-dose 3; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 4 or Placebo-dose 4; Drug: SHR2150；Placebo; Single dose；SHR2150-dose 5 or Placebo-dose 5

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Measure Description	Time Frame
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
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [AUC0-∞]	The area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.	Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ：[t1/2]	Terminal Half-life	Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma： [Tmax]	Time to Maximum Observed Concentration	Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [Cmax]	Maximum Observed Plasma Concentration	Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [CL/F]	Apparent clearance	Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [Vz/F]	Apparent volume of distribution	Up to 96hours
Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [MRT]	Mean retention time	Up to 96hours
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

Collaborators and Investigators

• Sponsor: Jiangsu HengRui Medicine Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 22, 2021
• Primary Completion (ACTUAL): November 10, 2021
• Study Completion (ACTUAL): November 10, 2021

Study Registration Dates

• First Submitted: March 10, 2021
• First Submitted That Met QC Criteria: March 15, 2021
• First Posted (ACTUAL): March 17, 2021

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 24, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: SHR2150-I-103

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No