Single Escalating Dose Study Of HSK7653 In Healthy Subjects

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Primary Purpose

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

HSK7653

Placebo

About this trial

This is an interventional treatment trial for T2DM (Type 2 Diabetes Mellitus)

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Peking Union Medical College Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HSK7653

Placebo

Arm Description

Single dose, oral

Outcomes

Primary Outcome Measures

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

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

Secondary Outcome Measures

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)

Maximum Observed Plasma Concentration (Cmax)

Time to Reach Maximum Observed Plasma Concentration (Tmax)

Plasma Decay Half-Life (t1/2)

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

Full Information

NCT ID

NCT05983289

First Posted

August 1, 2023

Last Updated

August 1, 2023

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT05983289

Brief Title

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

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Completed

Study Start Date

May 8, 2018 (Actual)

Primary Completion Date

July 3, 2019 (Actual)

Study Completion Date

July 3, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Haisco Pharmaceutical Group Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

No

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

T2DM (Type 2 Diabetes Mellitus)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

62 (Actual)

8. Arms, Groups, and Interventions

Arm Title

HSK7653

Arm Type

Experimental

Arm Description

Single dose, oral

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Single dose, oral

Intervention Type

Drug

Intervention Name(s)

HSK7653

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

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 Outcome Measure Information:

Title

Area Under the Curve From Time Zero to Last Quantifiable Concentration

Description

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

Time Frame