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Completed

NCT Number: NCT04802811

A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ,Pharmacodynamics of Oral 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.

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beijing youan Hospital,Capital medical university

Beijing, Beijing Municipality, 10069, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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..
  • 12-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;
  • Other conditions that the investigator believes the subject is not suitable.

Treatment and study plan

SHR2150;Placebo

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Jiangsu HengRui Medicine Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Mar 17, 2021
Registry last updated
Dec 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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