Single Escalating Dose Study Of HSK7653 In Healthy Subjects
- Registration Number
- NCT05983289
- Lead Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 62
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description HSK7653 HSK7653 Single dose, oral Placebo Placebo Single dose, oral
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Peking Union Medical College Hospital
🇨🇳Beijing, Beijing, China