Status:
COMPLETED
Single Escalating Dose Study Of HSK7653 In Healthy Subjects
Lead Sponsor:
Haisco Pharmaceutical Group Co., Ltd.
Conditions:
T2DM (Type 2 Diabetes Mellitus)
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 HSK7...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 8 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 3 2019
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT05983289
Start Date
May 8 2018
End Date
July 3 2019
Last Update
August 9 2023
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032