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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Basic Science
• Intervention / Treatment: Drug: RAY1225

• Study Type: Interventional
• Enrollment (Estimated): 68
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Guan Professor; Phone Number: 0769-81368666; Email: gdhygh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A; Single subcutaneous injection of RAY1225 3mg (test formulation)	Drug: RAY1225; Single subcutaneous injection of RAY1225 3mg
Active Comparator: group B; Single subcutaneous injection of RAY1225 3mg(reference formulation)	Drug: RAY1225; Single subcutaneous injection of RAY1225 3mg

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): September 21, 2026
• Primary Completion (Estimated): November 5, 2026
• Study Completion (Estimated): December 2, 2026

Study Registration Dates

• First Submitted: September 14, 2026
• First Submitted That Met QC Criteria: September 14, 2026
• First Posted (Actual): September 18, 2026

Study Record Updates

• Last Update Posted (Actual): September 18, 2026
• Last Update Submitted That Met QC Criteria: September 14, 2026
• Last Verified: September 1, 2026

More Information

Terms related to this study

• Keywords: bioequivalence
• Other Study ID Numbers: RAY1225-26-18

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No