Basic SciencePhase 1NCT07827027
Evaluation of the Bioequivalence of RAY1225 Injection in Healthy Participants
A Phase 1 study testing RAY1225 in people with Basic Science, run by Guangdong Raynovent Biotech Co., Ltd.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Basic Science
- What is being tested?
- RAY1225
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- No sites listed yet
- Study dates
- 21 Sep 2026to 2 Dec 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
- No healthy volunteers
- Adult
Who may be able to join
- 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.
- Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Participants (including partners) must use reliable methods of contraception during the study and until 3 months following the last dose of investigational product.
- 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.
Who cannot join
- 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);
- A history of hypoglycemic episodes within 12 months prior to screening;
- Major surgery or severe infection within 12 weeks prior to screening;
- Acute illness occurring from the time of signing the informed consent form to the administration of the investigational drug;
- 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);
- 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);
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- 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;
- Vaccination within 4 weeks prior to screening, or planned vaccination during the trial period;
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
- Conditions
- Basic Science
- Being tested
- RAY1225
- Keywords
- bioequivalence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAY1225Drug
Single subcutaneous injection of RAY1225 3mg
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Single subcutaneous injection of RAY1225 3mg (test formulation) Receives: Drug: RAY1225 |
| group B | Active comparator | Single subcutaneous injection of RAY1225 3mg(reference formulation) Receives: Drug: RAY1225 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])
Measured: Baseline through Day 43
PK: Maximum Concentration of RAY1225
Measured: Baseline through Day 43
Secondary outcomes (1)
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)
Measured: Baseline through Day 43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2026
- Study start21 Sep 2026 (estimated)
- Primary completion5 Nov 2026 (estimated)
- Study completion2 Dec 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 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
- NCT07827027
- Sponsor's protocol ID
- RAY1225-26-18
- Status last verified
- Sep 2026
- First submitted
- 14 Sep 2026
- Last updated
- 18 Sep 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Bioequivalence of RAY1225 Injection in Healthy Participants in a Single-center, Randomized, Open-label, Parallel Study
- ClinicalTrials.gov ID
- NCT07827027
- Acronym / sponsor ID
- RAY1225-26-18
- Conditions
- Basic Science
- Keywords
- bioequivalence
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 21 Sep 2026 (estimated)
- Primary completion
- 5 Nov 2026 (estimated)
- Study completion
- 2 Dec 2026 (estimated)
- First posted
- 18 Sep 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 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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: RAY1225Single subcutaneous injection of RAY1225 3mg (test formulation) |
| group B | Active comparator | Drug: RAY1225Single subcutaneous injection of RAY1225 3mg(reference formulation) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
- Participants must be willing and able to adhere to the visit schedule and protocol requirements and be available to complete the study.
- Participants (including partners) must use reliable methods of contraception during the study and until 3 months following the last dose of investigational product.
- 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.
Key exclusion criteria (9 listed)
- 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);
- A history of hypoglycemic episodes within 12 months prior to screening;
- Major surgery or severe infection within 12 weeks prior to screening;
- Acute illness occurring from the time of signing the informed consent form to the administration of the investigational drug;
- 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);
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 |
|---|---|---|
| RAY1225Single subcutaneous injection of RAY1225 3mg | Drug | group A, group B |
Primary outcome
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t])
Time frame: Baseline through Day 43
PK: Maximum Concentration of RAY1225
Time frame: Baseline through Day 43
1 secondary outcome
Number and severity of participants with Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events(SAE)
Time frame: Baseline through Day 43
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 18 Sep 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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RAY1225 in people with Basic Science, run by Guangdong Raynovent Biotech Co., Ltd.
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 9 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 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Guan Professor (0769-81368666, gdhygh@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of RAY1225 From Time Zero to T (AUC[0-t]) (time frame: Baseline through Day 43). 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 18 Sep 2026.