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

NCT04802811 | Completed Phase 1

• 1 other identifier: SHR2150-I-103
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ：[AUC0-last]

  Up to 96hours

• Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [AUC0-∞]

  Up to 96hours

• Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ：[t1/2]

  Up to 96hours

• Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma： [Tmax]

  Up to 96hours

• Pharmacokinetic parameters of SHR2150, , main metabolite and identified major metabolites in plasma ： [Cmax]

  Up to 96hours

Study Arms (5)

Treatment group A

EXPERIMENTAL

Drug: SHR2150；Placebo

Treatment group B

EXPERIMENTAL

Drug: SHR2150；Placebo

Treatment group C

EXPERIMENTAL

Drug: SHR2150；Placebo

Treatment group D

EXPERIMENTAL

Drug: SHR2150；Placebo

Treatment group E

EXPERIMENTAL

Drug: SHR2150；Placebo

Interventions

SHR2150；Placebo DRUG

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

Treatment group A

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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..
• 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.
• Have any drug that inhibits or induces liver metabolism within 1 month.
• 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;

Sponsors & Collaborators

• Jiangsu HengRui Medicine Co., Ltd.: lead

Study Sites (1)

Beijing youan Hospital,Capital medical university

Beijing, Beijing Municipality, 10069, China

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 17, 2021
• Study Start: March 22, 2021
• Primary Completion: November 10, 2021
• Study Completion: November 10, 2021
• Last Updated: December 28, 2021

Record last verified: 2021-03

Locations

CN (1)