Clinical trial NCT05983289: Single Escalating Dose Study Of HSK7653 In Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: T2DM (Type 2 Diabetes Mellitus)
Lead sponsor: Haisco Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-08-09
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
timeFrame: First dose of study drug up to 29 days after last dose of study drug
Secondary outcomes:
measure: Area Under the Curve From Time Zero to Last Quantifiable Concentration
timeFrame: 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;
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: 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;
measure: Time to Reach Maximum Observed Plasma Concentration (Tmax)
timeFrame: 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;
measure: Plasma Decay Half-Life (t1/2)
timeFrame: 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;
measure: Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration
timeFrame: 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;
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Hongzhong Liu
role: PRINCIPAL_INVESTIGATOR
References: