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

NCT07460284 | Not Yet Recruiting Phase 1

• 1 other identifier: RAY1225-25-16
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Basic Science

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Occurrence of adverse events/significant adverse events/serious adverse events

  DAY1~DAY60

Study Arms (1)

RAY1225

EXPERIMENTAL

Drug: 14C-RAY1225

Interventions

14C-RAY1225 DRUG

subcutaneous injection

RAY1225

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;
• Healthy adult males aged 18-55 years (inclusive, based on the time of signing the ICF);
• Weight ≥ 50 kg, and body mass index (BMI) = weight (kg)/height2 (m 2) between 20.0-35.0 kg/m2 (inclusive);
• 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

You may not qualify if:

• 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;
• History of hypoglycemic episodes within 12 months prior to screening;
• Major surgery or serious infection within 12 weeks prior to screening;
• Acute disease from the signing of the ICF to the administration of the investigational drug;
• 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;
• Participants who are not otherwise eligible to participate in this study.

Sponsors & Collaborators

• Guangdong Raynovent Biotech Co., Ltd: lead

Study Sites (1)

Shandong Provincial Qianfoshan Hospital

Jinan, Shandong, China

Location

Central Study Contacts

Zhao, Professor

CONTACT

053189268311; qylcsyllwyh@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2026
• First Posted: March 10, 2026
• Study Start: March 15, 2026
• Primary Completion (Estimated): October 14, 2026
• Study Completion (Estimated): October 28, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)