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

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07827027

Enrollment

Registered

2026-09-18

Start date

2026-09-21

Completion date

2026-12-02

Last updated

2026-09-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Basic Science

Keywords

bioequivalence

Brief summary

This is a single-center, randomized, open, parallel-designed bioequivalence study aimed at evaluating the pharmacokinetic differences of RAY1225 injection after site and batch changes compared to before the changes.

Interventions

DRUGRAY1225

Single subcutaneous injection of RAY1225 3mg

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 55 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])	Baseline through Day 43
PK: Maximum Concentration of RAY1225	Baseline through Day 43

Secondary

Measure	Time frame
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)	Baseline through Day 43

Contacts

CONTACTGuan Professor

gdhygh@163.com0769-81368666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 19, 2026