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CompletedNCT04354090Updated Apr 21, 2020

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

A Phase 1 interventional study of JY09 in Diabetes Mellitus, Type 2, sponsored by Beijing Dongfang Biotech Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-21.

Sponsored by Beijing Dongfang Biotech Co., Ltd. · Phase 1, Interventional, and Other

From the registry’s dates

  • Registered 1 year 11 months after the study started (first participant enrolled Apr 2018, registered Apr 2020).
Phase
Phase 1
Study type
Interventional
Enrollment
41
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus, Type 2
03

In context

Diabetes Mellitus, Type 2

9,362 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,317 are open to participants now.

This study's enrollment of 41 is below the median of 80 across 7,528 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Beijing Dongfang Biotech Co., Ltd. is the lead sponsor of 6 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Randomized
Intervention model
Sequential assignment
Masking
Double (Participant, Investigator)
Enrollment
41 participants (actual)

Study arms

  • Experimental
    Cohort 0.3-mg

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

    Drug: JY09

  • Experimental
    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

    Drug: JY09

  • Experimental
    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

    Drug: JY09

  • Experimental
    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

    Drug: JY09

  • Experimental
    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

    Drug: JY09

Interventions

  • DrugJY09

    Subcutaneous injection

    Also known as: Placebo

06

What researchers measure

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

    Average Cmax of each dose level

    Time frame: Up To day 42

  2. Pharmacodynamics parameters: AUC

    Average AUC follewing single dose of each doase level

    Time frame: Up to day 42

  3. Pharmacodynamics parameters: Half-life

    Average Half-life of each dose level

    Time frame: Up to day 42

  4. Pharmacokinetics parameters

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

    Time frame: Day 5

  5. Immunogenicity

    Anti-JY09 antibody incidence at each dose level

    Time frame: Up To day 42

07

Study locations

1 site
  • Nanjing Drum Tower Hospital
    Nanjing, Jiangsu 210008, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04354090
Lead sponsor
Beijing Dongfang Biotech Co., Ltd.
Responsible party
Sponsor
First posted
Apr 21, 2020
Start date
Apr 26, 2018
Primary completion
Dec 27, 2018
Completion
Jun 22, 2019
Last update
Apr 21, 2020

Study contacts

Juan Li, M.D.
principal investigator · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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