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A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics ，Pharmacodynamics of Oral SHR2150 in Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

NCT04802811•Jiangsu HengRui Medicine Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 45 years

Sex

ALL

Healthy Volunteers

Yes

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;
+6 more criteria

Locations (1)

Beijing youan Hospital,Capital medical university

Beijing, Beijing Municipality, China

Key Dates

Start Date

March 22, 2021

Primary Completion Date

November 10, 2021

Completion Date

November 10, 2021

Last Updated

December 28, 2021

Enrollment

ACTUAL participants

Conditions

HIV-1 Infection

Interventions

SHR2150；Placebo

DRUG

SHR2150；Placebo

DRUG

SHR2150；Placebo

DRUG

SHR2150；Placebo

DRUG

SHR2150；Placebo

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 28, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Change in Body Weight and BMI in PWH with DOR/3TC/TDF Compared with INSTI

Implementation of Out-of-HOspital Administration of the Long-Acting Cabotegravir+Rilpivirine

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