Basic SciencePhase 1NCT07460284
A Mass Balance Study Of 14C-RAY1225 Injection In Healthy Chinese Participants
A Phase 1 study testing 14C-RAY1225 in people with Basic Science, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
This is an open-label, single-center, single-dose study. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Basic Science
- What is being tested?
- 14C-RAY1225
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteChina
- Study dates
- 15 Mar 2026to 28 Oct 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Shandong Provincial Qianfoshan Hospital
Jinan, Shandong
Zhao, Professor, 053189268311, qylcsyllwyh@163.com
About this study
Official title: A Mass Balance Study of 14C-RAY1225 Injection in Healthy Chinese Participants
This is an open-label, single-center, single-dose study.
- Conditions
- Basic Science
- Being tested
- 14C-RAY1225
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
14C-RAY1225Drug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| RAY1225 | Experimental | Not described Receives: Drug: 14C-RAY1225 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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;
Measured: 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);
Measured: DAY1~DAY60
Secondary outcomes (1)
Occurrence of adverse events/significant adverse events/serious adverse events
Measured: DAY1~DAY60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start15 Mar 2026 (estimated)
- Primary completion14 Oct 2026 (estimated)
- Study completion28 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Basic ScienceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Raynovent Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460284
- Sponsor's protocol ID
- RAY1225-25-16
- Status last verified
- Feb 2026
- First submitted
- 27 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mass Balance Study of 14C-RAY1225 Injection in Healthy Chinese Participants
- ClinicalTrials.gov ID
- NCT07460284
- Acronym / sponsor ID
- RAY1225-25-16
- Conditions
- Basic Science
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 14 Oct 2026 (estimated)
- Study completion
- 28 Oct 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is an open-label, single-center, single-dose study.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RAY1225 | Experimental | Drug: 14C-RAY1225 |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 14C-RAY1225subcutaneous injection | Drug | RAY1225 |
Primary outcome
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;
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
1 secondary outcome
Occurrence of adverse events/significant adverse events/serious adverse events
Time frame: DAY1~DAY60
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 14C-RAY1225 in people with Basic Science, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhao, Professor (053189268311, qylcsyllwyh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total radioactivity recovery and cumulative recovery in urine and feces in each time period; (time frame: DAY1~DAY60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.