Single Escalating Dose Study Of HSK7653 In Healthy Subjects

Haisco Pharmaceutical Group

Status and phase

Completed

Phase 1

Conditions

T2DM (Type 2 Diabetes Mellitus)

Treatments

Drug: Placebo

Drug: HSK7653

Study type

Interventional

Funder types

Industry

Identifiers

NCT05983289

HSK7653-101

Details and patient eligibility

About

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

Enrollment

62 patients

Sex

All

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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