T2DM (Type 2 Diabetes Mellitus)
Conditions
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
Interventions
DRUGHSK7653
HSK7653 tablets in six doses beginning at 5 mg and rising to 150 mg
DRUGPlacebo
Matching placebo tables in six doses beginning at 5 mg and rising to 150 mg
Sponsors
Haisco Pharmaceutical Group Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs) | First dose of study drug up to 29 days after last dose of study drug | Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Curve From Time Zero to Last Quantifiable Concentration | Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration; | Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast) |
| Maximum Observed Plasma Concentration (Cmax) | Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration; | Maximum Observed Plasma Concentration (Cmax) |
| Time to Reach Maximum Observed Plasma Concentration (Tmax) | Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration; | Time to Reach Maximum Observed Plasma Concentration (Tmax) |
| Plasma Decay Half-Life (t1/2) | Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration; | Plasma decay half-life is the time measured for the plasma concentration to decrease by one half. |
| Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration | Pre dose and at 0.25, 0.5, 1, 1.5, 2, 4, 6, 8, 10, 12, 24, 72, 168 (day 8), 336 (day 15), 504(day 22), 672 (day 29) hours following single dose administration; | Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration |
Countries
China
Outcome results
None listed