NCT05983289

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 8, 2018

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 3, 2019

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

August 1, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 9, 2023

Completed
Last Updated

August 9, 2023

Status Verified

July 1, 2023

Enrollment Period

1.2 years

First QC Date

August 1, 2023

Last Update Submit

August 1, 2023

Conditions

T2DM (Type 2 Diabetes Mellitus)

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Area Under the Curve From Time Zero to Last Quantifiable Concentration

    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)

    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)

    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)

    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

    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;

Study Arms (2)

HSK7653

EXPERIMENTAL

Single dose, oral

Drug: HSK7653

Placebo

PLACEBO COMPARATOR

Single dose, oral

Drug: Placebo

Interventions

HSK7653DRUG

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

HSK7653
PlaceboDRUG

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

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100032, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Hongzhong Liu

    Peking Union Medical College Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2023

First Posted

August 9, 2023

Study Start

May 8, 2018

Primary Completion

July 3, 2019

Study Completion

July 3, 2019

Last Updated

August 9, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)