CompletedPhase 1

Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of JY09

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

Lead sponsor

Beijing Dongfang Biotech Co., Ltd.

Asset

JY09

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 18-26•Healthy volunteers

Primary endpoint

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04354090

Org study IDDFBT-JY09-101a

Timeline

Milestones

Study start2018-04-26actual

Primary completion2018-12-27actual

Study completion2019-06-22actual

Study first posted2020-04-21actual

Last update posted2020-04-21actual

Assets

Investigational agents

JY09

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age45 Years

SexAll

Healthy volunteersAccepted

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

Endpoints (0)

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.

No endpoints recorded for this trial.

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.