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

• ClinicalTrials.gov Identifier: NCT04802811
• Recruitment Status: Completed
• First Posted: March 17, 2021
• Last Update Posted: December 28, 2021
• Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Information provided by (Responsible Party): Jiangsu HengRui Medicine Co., Ltd.

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
HIV-1 Infection	Drug: SHR2150；Placebo	Phase 1

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 37 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Other
• 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
• Actual Study Start Date: March 22, 2021
• Actual Primary Completion Date: November 10, 2021
• Actual Study Completion Date: November 10, 2021

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 :

1. The incidence and severity of treatment-related adverse events as assessed by CTCAE v5.0. [ Time Frame: 9 DAYS for Group A.B.C.D.E ]

Secondary Outcome Measures :

1. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ：[AUC0-last] [ Time Frame: Up to 96hours ]
   The area under the concentration-time curve from time zero (pre-dose) to last time.
2. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [AUC0-∞] [ Time Frame: Up to 96hours ]
   The area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time.
3. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ：[t1/2] [ Time Frame: Up to 96hours ]
   Terminal Half-life
4. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma： [Tmax] [ Time Frame: Up to 96hours ]
   Time to Maximum Observed Concentration
5. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [Cmax] [ Time Frame: Up to 96hours ]
   Maximum Observed Plasma Concentration
6. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [CL/F] [ Time Frame: Up to 96hours ]
   Apparent clearance
7. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [Vz/F] [ Time Frame: Up to 96hours ]
   Apparent volume of distribution
8. Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [MRT] [ Time Frame: Up to 96hours ]
   Mean retention time
9. Pharmacodynamics: Changes in Cytokines in Serum: interferon γ-inducible protein-10 [ Time Frame: Up to 48hhours ]
10. Pharmacodynamics: Changes in Cytokines in Serum: Interferon-α [ Time Frame: Up to 48hours ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 45 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

China, Beijing

Beijing youan Hospital,Capital medical university

Beijing, Beijing, China, 10069

Sponsors and Collaborators

Jiangsu HengRui Medicine Co., Ltd.

More Information

• Responsible Party: Jiangsu HengRui Medicine Co., Ltd.
• ClinicalTrials.gov Identifier: NCT04802811
• Other Study ID Numbers: SHR2150-I-103
• First Posted: March 17, 2021
• Last Update Posted: December 28, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No