The PK/PD Study of SHR0532 Tablets in Healthy Subjects

NCT ID: NCT03645278

Last Updated: 2018-08-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-24
• Study Completion Date: 2019-04-30

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

SHR0532

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

Group Type: EXPERIMENTAL

SHR0532

Intervention Type: DRUG

Ascending dose oral adminstration

Placebo

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

Group Type: EXPERIMENTAL

Placebo

Intervention Type: DRUG

Ascending dose oral administration

Interventions

SHR0532

Ascending dose oral adminstration

Intervention Type: DRUG

Placebo

Ascending dose oral administration

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. males or females, aged 18-45

2. subjects have no cardiovascular disease, with sitting blood pressure: 90mmHg ≤SBP<140mmHg and 60mmHg ≤DBP<90mmHg;

3. 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

4. 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

1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or total bilirubin > 1.5 x ULN during screening/baseline;

2. Serum creatinine>ULN)during screening/baseline;

3. Human immunodeficiency virus antibody (HIV-ab), syphilis serological examination, hepatitis b virus surface antigen (HBsAg), hepatitis c virus antibody (HCV-ab) test positive;

4. Known postural hypotension; the numeric difference of systolic blood pressure between both upper limbs >20mmHg；

5. A clinical history of arrhythmia；subjects with Electrocardiogram QTc prolongation（male>450ms；female>460ms）during screening；

6. A clinical history of hyperuricemia；serum uric acid > the upper limit of normal value (ULN) during screening;

7. A clinical history of diabetes；fasting plasma glucose or hemoglobin A1c exceeded the upper limit of normal value (ULN) during screening;

8. Subjects with previous GI discomfort -abdominal pain, diarrhea, and nausea 3 months prior to screening；

9. A clinical history of acute or chronic kidney disease;

10. 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jiangsu HengRui Medicine Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yuanwei Jia, Ph.D.

Role: CONTACT

jiayuanwei123925@foxmail.com

+86-15155324471

Jie Shen, Ph.D.

Role: CONTACT

shenjie-yjs@qq.com

+86-15155324471

Other Identifiers

SHR0532-101

Identifier Type: -

Identifier Source: org_study_id