Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

NCT ID: NCT04354090

Last Updated: 2020-04-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-26
• Study Completion Date: 2019-06-22

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Cohort 0.3-mg

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

Group Type: EXPERIMENTAL

JY09

Intervention Type: DRUG

Subcutaneous injection

Cohort 0.7-mg

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

Group Type: EXPERIMENTAL

JY09

Intervention Type: DRUG

Subcutaneous injection

Cohort 1.5-mg

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

Group Type: EXPERIMENTAL

JY09

Intervention Type: DRUG

Subcutaneous injection

Cohort 3.0-mg

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

Group Type: EXPERIMENTAL

JY09

Intervention Type: DRUG

Subcutaneous injection

Cohort 6.0-mg

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

Group Type: EXPERIMENTAL

JY09

Intervention Type: DRUG

Subcutaneous injection

Interventions

JY09

Subcutaneous injection

Intervention Type: DRUG

Other Intervention Names

Placebo

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Beijing Dongfang Biotech Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Juan Li, M.D.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

DFBT-JY09-101a

Identifier Type: -

Identifier Source: org_study_id