The PK/PD Study of Multiple 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

NCT02361138

SHR3824-102

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 multiple-dose study the investigators evaluated the safety, tolerability and PK/PD profiles of SHR3824 in healthy subjects.

Enrollment: 48 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 acceptance of blood transfusion within 8 weeks.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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48 participants in 6 patient groups

Cohort SHR3824/Placebo 1.25 mg

Experimental group

Description:

SHR3824 1.25 mg/day or placebo for 10 days.

Treatment:

Drug: SHR3824

Drug: Placebo

Cohort SHR3824/Placebo 2.5 mg

Experimental group

Description:

SHR3824 2.5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.

Treatment:

Drug: SHR3824

Drug: Placebo

Cohort SHR3824/Placebo 5 mg

Experimental group

Description:

SHR3824 5 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.

Treatment:

Drug: SHR3824

Drug: Placebo

Cohort SHR3824/Placebo 10 mg

Experimental group

Description:

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

Treatment:

Drug: SHR3824

Drug: Placebo

Cohort SHR3824/Placebo 25 mg

Experimental group

Description:

SHR3824 25 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.

Treatment:

Drug: SHR3824

Drug: Placebo

Cohort SHR3824/Placebo 100mg

Experimental group

Description:

SHR3824 100 mg/day or placebo for 10 days. The actual dose (mg) level selected for each cohort may be modified based on evaluation of preliminary safety, pharmacokinetic and pharmacodynamic data from previous cohort.

Treatment:

Drug: SHR3824

Drug: Placebo