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The PK/PD Study of SHR0532 Tablets in Healthy Subjects

Primary Purpose

Hypertension

Status

Unknown status

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

SHR0532

Placebo

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

males or females, aged 18-45
subjects have no cardiovascular disease, with sitting blood pressure: 90mmHg ≤SBP<140mmHg and 60mmHg ≤DBP<90mmHg;
body mass index (BMI) between 19 to 26, and a total body weight: male ≥50.0 kg and <90.0 kg; female ≥45.0 kg and <90.0 kg
Participant in general good health. No clinically significant findings in laboratory parameters or clinically significant abnormality on electrocardiogram, X-ray, Echocardiograph and B-type ultrasonic

Exclusion Criteria:

Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin > 1.5 x ULN during screening/baseline;
Serum creatinine>ULN)during screening/baseline;
Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) test positive;
Known postural hypotension; the numeric difference of systolic blood pressure between both upper limbs >20mmHg；
A clinical history of arrhythmia；subjects with Electrocardiogram QTc prolongation（male>450ms；female>460ms）during screening；
A clinical history of hyperuricemia；serum uric acid > the upper limit of normal value (ULN) during screening;
A clinical history of diabetes；fasting plasma glucose or hemoglobin A1c exceeded the upper limit of normal value (ULN) during screening;
Subjects with previous GI discomfort -abdominal pain, diarrhea, and nausea 3 months prior to screening；
A clinical history of acute or chronic kidney disease;
Subjects with severe trauma or surgery within 3 months prior to the screening； 11.3 months prior to screening involved in any drug or medical device clinical subjects, or within 5 half-life of drugs (test drug half-life more than 3 months) before screening;

12.Pregnant or Serum β-hCG > 5mIU/mL at baseline or women who are breastfeeding; etc.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

SHR0532

Placebo

Arm Description

Up to 5 cohorts of healthy subjects will receive a single dose of oral SHR0532 tablet.

Up to 5 cohorts of healthy subjects will receive a single dose of oral placebo.

Outcomes

Primary Outcome Measures

Number of subjects with adverse events and serious adverse events

Secondary Outcome Measures

Area under the plasma concentration versus time curve (AUC) of SHR-0532

Maximum observed serum concentration (Cmax) of SHR-0532

Time to maximum observed serum concentration (tmax) of SHR-0532

Time to elimination half-life (t1/2) of SHR-0532

Apparent total clearance of the drug from plasma after oral administration (CL/F) of SHR-0532

Apparent volume of distribution after non-intravenous administration (V/F) of SHR-0532

Renal clearance of the drug from plasma (CLR) of SHR-0532

Cumulative amount of unchanged drug excreted into the urine(Ae) of SHR-0532

Full Information

NCT ID

NCT03645278

First Posted

August 12, 2018

Last Updated

August 22, 2018

Sponsor

Jiangsu HengRui Medicine Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03645278

Brief Title

The PK/PD Study of SHR0532 Tablets in Healthy Subjects

Official Title

A Phase I, Randomized, Double-Blind, Placebo-Controlled, Single-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of SHR0532 Tablets in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Unknown status

Study Start Date

August 24, 2018 (Anticipated)

Primary Completion Date

December 15, 2018 (Anticipated)

Study Completion Date

April 30, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Jiangsu HengRui Medicine Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

In the last four decades, several classes of diuretics have been the first line option for the therapy of widespread hypertension. However, all the classes of diuretics cause alteration of potassium homeostasis. The primary objective of this study is to assess the safety and tolerability of SHR0532 tablets in healthy subjects. In addition, this study will provide information on Pharmacokinetics and Pharmacodynamics of SHR0532 tablets in healthy subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

SHR0532

Arm Type

Experimental

Arm Description

Up to 5 cohorts of healthy subjects will receive a single dose of oral SHR0532 tablet.

Arm Title

Placebo

Arm Type

Experimental

Arm Description

Up to 5 cohorts of healthy subjects will receive a single dose of oral placebo.

Intervention Type

Drug

Intervention Name(s)

SHR0532

Intervention Description

Ascending dose oral adminstration

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Ascending dose oral administration

Primary Outcome Measure Information:

Title

Number of subjects with adverse events and serious adverse events

Time Frame