Single Escalating Dose Study Of HSK7653 In Healthy Subjects

NCT ID: NCT05983289

Last Updated: 2023-08-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 62 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-08
• Study Completion Date: 2019-07-03

Brief Summary

To evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) characteristics of single dose of HSK7653 tablets in healthy adult subjects, and to identify the metabolites of HSK7653 in healthy adult subjects

Conditions

T2DM (Type 2 Diabetes Mellitus)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

HSK7653

Single dose, oral

Group Type: EXPERIMENTAL

HSK7653

Intervention Type: DRUG

HSK7653 tablets in six doses beginning at 5 mg and rising to 150 mg

Placebo

Single dose, oral

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo tables in six doses beginning at 5 mg and rising to 150 mg

Interventions

HSK7653

HSK7653 tablets in six doses beginning at 5 mg and rising to 150 mg

Intervention Type: DRUG

Placebo

Matching placebo tables in six doses beginning at 5 mg and rising to 150 mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age ≥18 and Age ≤60 years
• BMI ≥18 and BMI ≤ 25 kg/m2 (Body Mass Index)
• Able to understand the procedures of the study, provide written informed consent, and be willing to comply with the protocol of the study

Exclusion Criteria

• Any finding of the medical examination (physical examination, laboratory examination, 12-ECG, abdominal B-ultrasonography, etc) deviating from normal and of clinical relevance during screening
• Evidence or history of clinically significant renal, gastrointestinal (including pancreatitis), hepatic disease at the time of screening
• Has a positive result on screening for serum hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCVAb), Treponema pallidum antibody (TP-Ab) or human immunodeficiency virus (HIV)
• Treatment with an investigational drug within 3 months
• Fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 6 months after the last dose

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hongzhong Liu

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Countries

China

Other Identifiers

HSK7653-101

Identifier Type: -

Identifier Source: org_study_id