The PK/PD Study of Single Dose of SHR3824 in Healthy Volunteers

Hengrui Medicine

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes

Treatments: Drug: Placebo; Drug: SHR3824

Study type: Interventional

Funder types: Industry

Identifiers

NCT02356224

SHR3824-101

Details and patient eligibility

About

SHR3824 is a novel inhibitor of renal sodium-glucose cotransporter 2, allows an insulin-independent approach to improve type 2 diabetes hyperglycemia. In this single-dose study the investigators evaluated the safety, tolerablity and PK/PD profiles of SHR3824 in healthy subjects.

Enrollment: 84 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Chinese male and female subjects aged 18 to 45 years.
• BMI:18 -25 kg/m2 .
• Healthy according to medical history, physical examination findings, 12-lead ECG findings, and clinical laboratory evaluations.

Exclusion criteria

• History of or current clinically significant medical illness as determined by the Investigator.
• History of clinically significant allergies, especially known hypersensitivity or intolerance to lactose.
• Pregnancy or breastfeeding .
• Significant acute or chronic medical illness, including renal impairment, or recent surgery.
• Donation of blood or plasma within the 4 weeks prior to the start of the study or acception of blood transfusion within 8 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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84 participants in 7 patient groups

Cohort 1

Experimental group

Description:

SHR3824 2.5 mg/day or placebo.

Treatment:

Drug: Placebo

Drug: SHR3824

Cohort 2

Experimental group

Description:

SHR3824 5 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.

Treatment:

Drug: Placebo

Drug: SHR3824

Cohort 3

Experimental group

Description:

SHR3824 10 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.

Treatment:

Drug: Placebo

Drug: SHR3824

Cohort 4

Experimental group

Description:

SHR3824 25 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.

Treatment:

Drug: Placebo

Drug: SHR3824

Cohort 5

Experimental group

Description:

SHR3824 50 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.

Treatment:

Drug: Placebo

Drug: SHR3824

Cohort 6

Experimental group

Description:

SHR3824 100 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.

Treatment:

Drug: Placebo

Drug: SHR3824

Cohort 7

Experimental group

Description:

SHR3824 200 mg/day or placebo. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohorts.

Treatment:

Drug: Placebo

Drug: SHR3824