Single Escalating Dose Study Of HSK7653 In Healthy Subjects

Haisco Pharmaceutical Group Co., Ltd.62 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

T2DM (Type 2 Diabetes Mellitus)

Interventions

HSK7653DRUG

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

PlaceboDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.

Time frame: First dose of study drug up to 29 days after last dose of study drug

Secondary Outcomes

Area Under the Curve From Time Zero to Last Quantifiable Concentration

Area under the plasma concentration time-curve from zero to the last measured concentration (AUClast)

Time frame: 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 frame: 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)

Time frame: 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 (t1/2)

Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.

Time frame: 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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.