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Delfa

← All trials/NCT07827027

Not yet recruitingPhase 1

Evaluation of the Bioequivalence of RAY1225 Injection in Healthy Participants

Evaluation of the Bioequivalence of RAY1225 Injection in Healthy Participants in a Single-center, Randomized, Open-label, Parallel Study

Asset

RAY1225

Subcutaneous · GLP-1 / GIP dual

Listed sites

0

Recruiting sites

-

Estimated enrollment

68

Study population

Basic Science

Eligibility highlights

•BMI ≤28

Primary endpoints

•AUC of RAY1225•PK: Maximum Concentration of RAY1225

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 IDNCT07827027
Org study IDRAY1225-26-18

Timeline

Milestones

Study first posted2026-09-18actual
Last update posted2026-09-18actual
Study start2026-09-21estimated
Primary completion2026-11-05estimated
Study completion2026-12-02estimated

Assets

Investigational agents

Who this study enrolls

Basic Science

Who can enroll

Minimum age18 Years
Maximum age55 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Signature of a dated Informed Consent Form (ICF) indicating that the subject has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment.

2. Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.

3. Participants (including partners) must use reliable methods of contraception during the study and until 3 months following the last dose of investigational product.

4. Body weight is no less than 55 kg in males and no less than 50 kg in females. Body mass index (BMI) 22≤BMI<28 kg/m2.

Exclusion criteria

1. A history of medullary thyroid carcinoma (MTC) or current diagnosis of MTC, or a family history of MTC (grandparents, parents, and siblings), or a diagnosis of multiple endocrine neoplasia type 2 (MEN2);

2. A history of hypoglycemic episodes within 12 months prior to screening;

3. Major surgery or severe infection within 12 weeks prior to screening;

4. Acute illness occurring from the time of signing the informed consent form to the administration of the investigational drug;

5. Clinically significant abnormalities in physical examination, vital signs, laboratory tests (complete blood count, blood biochemistry, urinalysis, coagulation function, serum calcitonin), thyroid ultrasound, abdominal color Doppler ultrasound (liver, gallbladder, pancreas, spleen, and kidneys), or chest X-ray (posteroanterior and lateral views);

6. Positive for any of the following at screening: hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), or Treponema pallidum antibody (TP-Ab);

7. Clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening, or QTcF > 450 ms on ECG, or a family history of long QT syndrome or Brugada syndrome;

8. Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period;

9. Use of any prescription drugs, over-the-counter drugs, or traditional Chinese medicines within 4 weeks prior to screening, or planned concomitant use during the trial period.

Endpoints (3)

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.

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])

Time frame:Baseline through Day 43

concentration, descriptive

Primary/protocol endpoint

PK: Maximum Concentration of RAY1225

Time frame:Baseline through Day 43

concentration, descriptive

Secondary/protocol endpoint

Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)

Time frame:Baseline through Day 43

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 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 November 5, 2026 snapshot.