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NCT Number: NCT07460284

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

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

14C-RAY1225

Drug

subcutaneous injection

Primary outcomes

  1. Total radioactivity recovery and cumulative recovery in urine and feces in each time period;

    Time frame: DAY1~DAY60

    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;

  2. 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);

    Time frame: DAY1~DAY60

Secondary outcomes

  1. Occurrence of adverse events/significant adverse events/serious adverse events

    Time frame: DAY1~DAY60

Study contacts

Contact information is provided by the study sponsor or research team.

Zhao, Professor

CONTACT

[email protected]

053189268311

Sponsors and collaborators

Lead sponsor

Guangdong Raynovent Biotech Co., Ltd

Industry

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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