A Mass Balance Study Of 14C-RAY1225 Injection In Healthy Chinese Participants

A Mass Balance Study of 14C-RAY1225 Injection in Healthy Chinese Participants

This is an open-label, single-center, single-dose study.

Study Overview

• Status: Not yet recruiting
• Conditions: Basic Science
• Intervention / Treatment: Drug: 14C-RAY1225

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Zhao, Professor; Phone Number: 053189268311; Email: qylcsyllwyh@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Qianfoshan Hospital
      • Contact: Zhao, Professor; Phone Number: 053189268311; Email: qylcsyllwyh@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Participants who sign the informed consent form, fully understand the content, process, and possible adverse reactions of the study, and are able to complete the study as required by the study protocol;
2. Healthy adult males aged 18-55 years (inclusive, based on the time of signing the ICF);
3. Weight ≥ 50 kg, and body mass index (BMI) = weight (kg)/height2 (m 2) between 20.0-35.0 kg/m2 (inclusive);
4. Participants (including partners) who agree to voluntarily use effective contraception from screening until 6 months after the investigational drug administration and have no sperm donation plan. For specific contraceptive measures

Exclusion Criteria:

1. Subjects with trauma, surgical scar, or skin lesions at the proposed administration site (abdomen) who are not suitable for subcutaneous injection as assessed by the investigator;
2. History of hypoglycemic episodes within 12 months prior to screening;
3. Major surgery or serious infection within 12 weeks prior to screening;
4. Acute disease from the signing of the ICF to the administration of the investigational drug;
5. Smoking more than 5 cigarettes per day within 12 weeks prior to screening, or unable to abstain from smoking within 7 days prior to admission and during the study;
6. Participants who are not otherwise eligible to participate in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: RAY1225	Drug: 14C-RAY1225; subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total radioactivity recovery and cumulative recovery in urine and feces in each time period;	To quantitatively analyze the total radioactivity in the excretions of healthy participants after subcutaneous injection of 14C-RAY1225, and to obtain the primary radioactivity recovery data and primary excretion pathways in humans;	DAY1~DAY60
Radioactivity of each metabolite in urine and feces as a percentage of the total administered dose and the circulating metabolites in plasma as a percentage of the total exposure AUC (%AUC);		DAY1~DAY60

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of adverse events/significant adverse events/serious adverse events	DAY1~DAY60

Collaborators and Investigators

• Sponsor: Guangdong Raynovent Biotech Co., Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2026
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): October 28, 2026

Study Registration Dates

• First Submitted: February 27, 2026
• First Submitted That Met QC Criteria: March 3, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 3, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: RAY1225-25-16

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