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Completed

NCT Number: NCT05983289

Single Escalating Dose Study Of HSK7653 In Healthy Subjects

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

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Key information

Conditions

T2DM (Type 2 Diabetes Mellitus) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HSK7653

Drug

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

Placebo

Drug

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Area Under the Curve From Time Zero to Last Quantifiable Concentration

    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;

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

  2. 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;

    Maximum Observed Plasma Concentration (Cmax)

  3. 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;

    Time to Reach Maximum Observed Plasma Concentration (Tmax)

  4. Plasma Decay Half-Life (t1/2)

    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 is the time measured for the plasma concentration to decrease by one half.

  5. Inhibition Rate of Dipeptidyl Peptidase 4 (DPP4) Activities following single dose administration

    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

Sponsors and collaborators

Lead sponsor

Haisco Pharmaceutical Group Co., Ltd.

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 9, 2023
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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