Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

NCT04354090 | Completed Phase 1

• 1 other identifier: DFBT-JY09-101a
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events and serious adverse events related to JY09

  Up to day 21

Secondary Outcomes (5)

• Pharmacodynamics parameters: Cmax

  Up To day 42

• Pharmacodynamics parameters: AUC

  Up to day 42

• Pharmacodynamics parameters: Half-life

  Up to day 42

• Pharmacokinetics parameters

  Day 5

• Immunogenicity

  Up To day 42

Study Arms (5)

Cohort 0.3-mg

EXPERIMENTAL

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

Drug: JY09

Cohort 0.7-mg

EXPERIMENTAL

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

Drug: JY09

Cohort 1.5-mg

EXPERIMENTAL

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

Drug: JY09

Cohort 3.0-mg

EXPERIMENTAL

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

Drug: JY09

Cohort 6.0-mg

EXPERIMENTAL

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

Drug: JY09

Interventions

JY09 DRUG

Subcutaneous injection

Also known as: Placebo

Cohort 0.3-mg; Cohort 0.7-mg; Cohort 1.5-mg; Cohort 3.0-mg; Cohort 6.0-mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Dongfang Biotech Co., Ltd.: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Juan Li, M.D.

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: April 21, 2020
• Study Start: April 26, 2018
• Primary Completion: December 27, 2018
• Study Completion: June 22, 2019
• Last Updated: April 21, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)