DelfaGLP-1 Atlas

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UnknownPhase 1

a Study of JY09 in Chinese Healthy Subjects

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

Asset

GLP-1 / incretin class catch-all

Listed sites

0

Recruiting sites

—

Enrollment

26

estimated

Study population

Healthy volunteers

Key I/E criteria

•BMI 18-28•Healthy volunteers

Primary endpoint

•Pharmacokinetics (PK)

Identifiers

Registered as

NCT IDNCT02971722
Org study IDDFBT-JY09-1

Timeline

Milestones

Study first posted2016-11-23estimated
Last update posted2016-12-07estimated
Study start2016-12 (month precision)
Primary completion2017-05estimated (month precision)
Study completion2018-03estimated (month precision)

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age18 Years
Maximum age45 Years
SexAll
Healthy volunteersAccepted

Inclusion criteria

•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

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 or family history of long QT syndrome (grandparents, parents and siblings)
•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.

Endpoints (4)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
3
Glycemic / diabetes
1

Glycemic / diabetes

1 endpoint
Secondary/protocol endpoint/low confidence

Pharmacodynamics (PD）

Time frame:Baseline through day29 of period

descriptive

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Pharmacokinetics (PK)

Time frame:Baseline through day29 of period

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

immunogenicity

Time frame:Baseline through day29 of period

Immunogenicity (ADA)

descriptive

Secondary/protocol endpoint

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

Time frame:baseline to 3 months(cohort1 and cohort 2)

Treatment-emergent AEs (any)

event count, event

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.