The PK/PD Study of SHR0532 Tablets in Healthy Subjects

Hengrui Medicine

Status and phase: Unknown; Phase 1

Conditions: Hypertension

Treatments: Drug: SHR0532; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03645278

SHR0532-101

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups

SHR0532

Experimental group

Description:

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

Treatment:

Drug: SHR0532

Placebo

Experimental group

Description:

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

Treatment:

Drug: Placebo