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Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

JY09

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Healthy subjects
Male's mass is ≥50 kg, female's mass is ≥45 kg, have a body mass index between 18 and 26 kg/m^2
Subjects or their legal representative signed informed consent
agree to use instruments of contraception from the time of the first dose until 6 months after the last dose of investigational drug, avoid pregnancy make yourself or your mate
Able to keep good communication with investigator and comply with the requirements of the clinical trials

Exclusion Criteria:

Smokers,quitting time less than 3 months , or can't quit smoking during the trial
Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing,or being treated for a direct lower gastrointestinal or using steroids
Participation in any clinical investigation within 3 months prior to dosing
Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing
Significant illness within 2 weeks prior to dosing,and investigator judge doesn't fit to participate in this trial
A history of clinical significance of abnormal ECG
A history of diabetes, hyperuricemia and hyperlipidemia
A history of acute or chronic bronchial spasms
Have clinical significant gastrointestinal diseases
Have serious, progressive, or uncontrolled organ or system diseases
Abuse of drug or alcohol within 12 months before first dosing
People who are pregnant, nursing mothers, or in the near future plan to be pregnant,or show pregnancy test positive before into group
Subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study

Sites / Locations

Nanjing Drum Tower Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Cohort 0.3-mg

Cohort 0.7-mg

Cohort 1.5-mg

Cohort 3.0-mg

Cohort 6.0-mg

Arm Description

Eligible subjects received 0.3 mg placebo or JY09 on day 1 in this cohort

Eligible subjects received 0.3 mg placebo or JY09 on days 1, and 0.7 mg placebo or JY09 on days 22

Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 1.5 mg placebo or JY09 on days 22

Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 3.0 mg placebo or JY09 on days 22

Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 1.0 mg placebo or JY09 on days 15, and 6.0 mg placebo or JY09 on days 30

Outcomes

Primary Outcome Measures

Incidence of adverse events and serious adverse events related to JY09

Secondary Outcome Measures

Pharmacodynamics parameters: Cmax

Average Cmax of each dose level

Pharmacodynamics parameters: AUC

Average AUC follewing single dose of each doase level

Pharmacodynamics parameters: Half-life

Average Half-life of each dose level

Pharmacokinetics parameters

OGTT test was conducter predose and 5 days after the target dose in each cohorts

Immunogenicity

Anti-JY09 antibody incidence at each dose level

Full Information

NCT ID

NCT04354090

First Posted

April 14, 2020

Last Updated

April 16, 2020

Sponsor

Beijing Dongfang Biotech Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04354090

Brief Title

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

Official Title

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09, a Long-acting Glucagon-like Peptide-1 Mimetic, in Healthy Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

April 26, 2018 (Actual)

Primary Completion Date

December 27, 2018 (Actual)

Study Completion Date

June 22, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Beijing Dongfang Biotech Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

JY09 is a glucagon-like peptide-1 (GLP-1) mimetic generated by genetic fusion of a Exendin-4 dimer to human immunoglobulin Fc. In this Double-blind, randomized, placebo-controlled trial, 41 healthy subjects received placebo or escalating doses of JY09 on day 1 in the first cohort, and on days 1 and 22 in the following sequential cohort 2-4, and on days 1, 15, and 30 in the cohort 5: cohort 1: 0.3 mg; cohort 2: 0.3 + 0.7 mg; cohort 3: 0.7+1.5 mg; cohort 4: 0.7+3.0 mg; and cohort 5: 0.7 + 1.5 + 6.0 mg. The primary endpoints were the incidence of adverse events and serious adverse events related to JY09. Secondary endpoints included pharmacodynamics and pharmacokinetics parameters, as well as anti-JY09 antibody incidence and titers.

6. Conditions and Keywords

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

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Other

Study Phase

Phase 1

Interventional Study Model

Sequential Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

41 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohort 0.3-mg

Arm Type

Experimental

Arm Description

Eligible subjects received 0.3 mg placebo or JY09 on day 1 in this cohort

Arm Title

Cohort 0.7-mg

Arm Type

Experimental

Arm Description

Eligible subjects received 0.3 mg placebo or JY09 on days 1, and 0.7 mg placebo or JY09 on days 22

Arm Title

Cohort 1.5-mg

Arm Type

Experimental

Arm Description

Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 1.5 mg placebo or JY09 on days 22

Arm Title

Cohort 3.0-mg

Arm Type

Experimental

Arm Description

Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 3.0 mg placebo or JY09 on days 22

Arm Title

Cohort 6.0-mg

Arm Type

Experimental

Arm Description

Eligible subjects received 0.7 mg placebo or JY09 on days 1, and 1.0 mg placebo or JY09 on days 15, and 6.0 mg placebo or JY09 on days 30

Intervention Type

Drug

Intervention Name(s)

JY09

Other Intervention Name(s)

Placebo

Intervention Description

Subcutaneous injection

Primary Outcome Measure Information:

Title

Incidence of adverse events and serious adverse events related to JY09

Time Frame

Up to day 21

Secondary Outcome Measure Information:

Title

Pharmacodynamics parameters: Cmax

Description

Average Cmax of each dose level

Time Frame

Up To day 42

Title

Pharmacodynamics parameters: AUC

Description

Average AUC follewing single dose of each doase level

Time Frame

Up to day 42

Title

Pharmacodynamics parameters: Half-life

Description

Average Half-life of each dose level

Time Frame

Up to day 42

Title

Pharmacokinetics parameters

Description

OGTT test was conducter predose and 5 days after the target dose in each cohorts

Time Frame

Day 5

Title

Immunogenicity

Description

Anti-JY09 antibody incidence at each dose level

Time Frame

Up To day 42

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy subjects Male's mass is ≥50 kg, female's mass is ≥45 kg, have a body mass index between 18 and 26 kg/m^2 Subjects or their legal representative signed informed consent agree to use instruments of contraception from the time of the first dose until 6 months after the last dose of investigational drug, avoid pregnancy make yourself or your mate Able to keep good communication with investigator and comply with the requirements of the clinical trials Exclusion Criteria: Smokers,quitting time less than 3 months , or can't quit smoking during the trial Use of any prescription drugs within 4 weeks prior dosing, or over-the-counter medication (vitamins, herbal supplements, dietary supplements) within 2 weeks prior to dosing,or being treated for a direct lower gastrointestinal or using steroids Participation in any clinical investigation within 3 months prior to dosing Donation or loss of 400 mL or more of blood within 8 weeks prior to first dosing Significant illness within 2 weeks prior to dosing,and investigator judge doesn't fit to participate in this trial A history of clinical significance of abnormal ECG A history of diabetes, hyperuricemia and hyperlipidemia A history of acute or chronic bronchial spasms Have clinical significant gastrointestinal diseases Have serious, progressive, or uncontrolled organ or system diseases Abuse of drug or alcohol within 12 months before first dosing People who are pregnant, nursing mothers, or in the near future plan to be pregnant,or show pregnancy test positive before into group Subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Juan Li, M.D.

Organizational Affiliation

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nanjing Drum Tower Hospital

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210008

Country

China

12. IPD Sharing Statement

Plan to Share IPD

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Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

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