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OpenTrials
Completed

NCT Number: NCT04354090

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

JY09

Drug

Subcutaneous injection

Other names: Placebo

Primary outcomes

  1. Incidence of adverse events and serious adverse events related to JY09

    Time frame: Up to day 21

Secondary outcomes

  1. Pharmacodynamics parameters: Cmax

    Time frame: Up To day 42

    Average Cmax of each dose level

  2. Pharmacodynamics parameters: AUC

    Time frame: Up to day 42

    Average AUC follewing single dose of each doase level

  3. Pharmacodynamics parameters: Half-life

    Time frame: Up to day 42

    Average Half-life of each dose level

  4. Pharmacokinetics parameters

    Time frame: Day 5

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

  5. Immunogenicity

    Time frame: Up To day 42

    Anti-JY09 antibody incidence at each dose level

Sponsors and collaborators

Lead sponsor

Beijing Dongfang Biotech Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Apr 21, 2020
Registry last updated
Apr 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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