Single Escalating Dose Study Of HSK7653 In Healthy Subjects

T2DM (Type 2 Diabetes Mellitus) Clinical Trial

Official title:

A Single Center, Randomized, Double-blind, Placebo-controlled Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Single Escalating Doses Of HSK7653 In Healthy Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05983289
• Other study ID #: HSK7653-101
• Status: Completed
• Phase: Phase 1
• Start date: May 8, 2018
• Est. completion date: July 3, 2019

Study information

• Verified date: July 2023
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: July 3, 2019
• Est. primary completion date: July 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• T2DM (Type 2 Diabetes Mellitus)

Intervention

Drug:
• HSK7653
HSK7653 tablets in six doses beginning at 5 mg and rising to 150 mg
• Placebo
Matching placebo tables in six doses beginning at 5 mg and rising to 150 mg

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Assessment by adverse event monitoring, 12 lead ECGs, vital signs and laboratory measurements.	First dose of study drug up to 29 days after last dose of study drug
Secondary	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)	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;
Secondary	Maximum Observed Plasma Concentration (Cmax)	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;
Secondary	Time to Reach Maximum Observed Plasma Concentration (Tmax)	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;
Secondary	Plasma Decay Half-Life (t1/2)	Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.	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;
Secondary	Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration	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;