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HealthyPhase 1NCT02971722

a Study of JY09 in Chinese Healthy Subjects

A Phase 1 study testing JY09 in people with Healthy, run by Beijing Dongfang Biotech Co., Ltd..

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

JY09，is a recombinant glucagon-like peptide-1 (GLP-1) receptor agonist,constructed with Exendin-4 and human Immunoglobulin G2 (IgG2) Fc fragment.Preclinical studies show that JY09 exhibit the expected GLP-1-mediated pharmacological effects on insulin secretion,glucose covering and islet cell recovering,as well as good… Read more about this study

Who is it for?
Ages 18 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Healthy
What is being tested?
JY09
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
No sites listed yet
Study dates
Dec 2016to Mar 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy subjects.
  • Male's mass is equal or greater than 50 kg, female's mass is equal or greater than 45 kg,have a body mass index (BMI) between 18 and 28 kilograms per square meter (kg/m^2), inclusive.
  • The subjects sign informed consent form voluntarily.
  • The subjects 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.
  • Participants will be able to keep good communication with investigator and comply with the requirements of the clinical trials

Who cannot join

  • 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 or family history of long QT syndrome (grandparents, parents and siblings)
Show all 21Show fewer
  • Have a family history of diabetes (grandparents, parents and siblings).
  • Have a history of acute or chronic bronchial spasms(including after treatment or no treatment of asthma and chronic obstructive pulmonary disease )
  • Have a history of drug allergy or atopic disease allergy(asthma, urticaria, eczema, dermatitis),or allergy history of trail drugs or similar drugs.
  • Have gastrointestinal diseases,such as history of liver disease, gastrointestinal disease,gastrointestinal surgery (appendix removed except) or chronic pancreatitis, or history of idiopathic acute pancreatitis that,in the opinion of the investigator,is clinical significant.
  • Have personal or family history of medullary thyroid cancer (MTC) or a hereditary disease that induce MTC .
  • Have a history of immunodeficiency disease,including human immunodeficiency virus (HIV) antibody positive.
  • Have a history of needlesickness that,in the opinion of the investigator,is clinical significant.
  • Have an unknown cause of infection.
  • In screening,any abnormal results of physical examination, vital signs,electrocardiogram (ECG) and clinical laboratory that,in the opinion of the investigator,is clinical significant.
  • Hepatitis b surface antigen or hepatitis c antibody positive, or treponema pallidum antibody positive.
  • Abuse of drug or alcohol within 12 months before first dosing,or in screening found evidence of abuse in laboratory tests.
  • People who are pregnant, nursing mothers, or in the near future plan to be pregnant,or show pregnancy test positive before into group.
  • In screening,lying position (after 3 minutes rest) systolic blood pressure outside the range 90 ~ 140 MMHG, or diastolic blood pressure outside the range 50-90 MMHG, or pulse (HR) outside the range 40 ~ 100 bpm, boundary value into the group.
  • Have chang of weight > 3 kg within 3 months by self-report.
  • Subjects who, in the opinion of the investigator, are in any way unsuitable to participate in the study.

About this study

Official title: Randomized,Double-blind,Placebo-controlled,Dose-escalating Phase I,Healthy Subjects Study of JY09,a Recombinant GLP-1 Receptor Agonist

JY09，is a recombinant glucagon-like peptide-1 (GLP-1) receptor agonist,constructed with Exendin-4 and human Immunoglobulin G2 (IgG2) Fc fragment.Preclinical studies show that JY09 exhibit the expected GLP-1-mediated pharmacological effects on insulin secretion,glucose covering and islet cell recovering,as well as good tolerance and safety.JY09 has been approved by China food and drug administration(CFDA) to enter the clinical research stage(Grant number 2016L04254).This study is designed to assess the safety,tolerability,pharmacokinetics,pharmacodynamics and potential immunogenicity of JY09 in healthy Chinese volunteers.

Conditions
Healthy
Being tested
JY09, Placebo
Keywords
GLP-1 receptor agonist

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JY09Drug

    2mg/1ml/bottle

  • PlaceboDrug

    1ml/bottle

Study groups in NCT02971722
Study groupRoleWhat they receive
0.3mg JY09(cohort 1)Experimental0.3mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
Receives: Drug: JY09
1.5mg JY09(cohort 1)Experimental1.5mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
Receives: Drug: JY09
6.0mg JY09(cohort 1)Experimental6.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
Receives: Drug: JY09
Placebo(cohort 1)Placebo comparatorPlacebo administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
Receives: Drug: Placebo
0.7mg JY09(cohort2)Experimental0.7mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
Receives: Drug: JY09
3.0mg JY09(cohort2)Experimental3.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
Receives: Drug: JY09
12.0mg JY09(cohort2)Experimental12.0mg JY09 administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
Receives: Drug: JY09
Placebo(cohort 2)Placebo comparatorPlacebo administered once subcutaneous injection to healthy participants in 1 of 3 treatment periods
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pharmacokinetics (PK)

    Area Under the Concentration Versus Time Curve (AUC) of JY09

    Measured: Baseline through day29 of period

Secondary outcomes (3)

  1. immunogenicity

    A measure of the body's immune response to JY09

    Measured: Baseline through day29 of period

  2. Number of participants with treatment-related adverse events as assessed by CTCAE v4.03

    Weight loss of subject is greater than 3 kg will be recorded as adverse events in a month

    Measured: baseline to 3 months(cohort1 and cohort 2)

  3. Pharmacodynamics (PD）

    Area Under the Concentration Versus Time Curve (AUC) of Glucose

    Measured: Baseline through day29 of period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2016 (estimated)
  2. Study startDec 2016
  3. Primary completionMay 2017 (estimated)
  4. Study completionMar 2018 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
26 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02971722
Sponsor's protocol ID
DFBT-JY09-1
Status last verified
Sep 2016
First submitted
17 Nov 2016
Last updated
7 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Thorkildsen C, Neve S, Larsen BD, Meier E, Petersen JS. Glucagon-like peptide 1 receptor agonist ZP10A increases insulin mRNA expression and prevents diabetic progression in db/db mice. J Pharmacol Exp Ther. 2003 Nov;307(2):490-6. doi: 10.1124/jpet.103.051987. Epub 2003 Sep 15.

    PubMed 12975499

  • Bradley DP, Kulstad R, Schoeller DA. Exenatide and weight loss. Nutrition. 2010 Mar;26(3):243-9. doi: 10.1016/j.nut.2009.07.008.

    PubMed 20152707

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JY09 in people with Healthy, run by Beijing Dongfang Biotech Co., Ltd..

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pharmacokinetics (PK) (time frame: Baseline through day29 of period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02971722, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2016.

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