Kidney ImpairmentPhase 1NCT06613763
A Study of RAY1225 in Participants With Impaired Kidney Function
A Phase 1 study testing RAY1225 in people with Kidney Impairment, run by Guangdong Raynovent Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Impairment
- 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
- 32 participants
- Where
- 1 siteChina
- Study dates
- 11 Sep 2024to 20 Jan 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index (BMI) ≥18 to ≤28kg/m2 and total body weight >50 kg(male) or >40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
- Ability to understand and willingness to sign a written informed consent form;
- Participants with normal renal function only:
- Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant；
- Glomerular filtration rate (GFR)≥ 90 mL/min and <130 mL/min ；
- Age, BMI, and sex comparable to those of subjects of renal impairment；
- Participants with severe renal impairment only:
- Diagnosis of CKD (any indicators of renal impairment or GFR < 60 mL/min/1.73 m2 for more than 3 months)；
Who cannot join
- Participants with an allergic disposition (multiple drug and food allergies) or who, have known allergies to RAY1225 or related compounds;
- Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
- Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months or donated blood or bleeding profusely (> 200 mL) in the 1 months;
- Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
- Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
- Participants with severe renal impairment only:
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- Participants with acute renal failure, or a kidney transplant history; or requiring renal dialysis during the study period;
- Hypertension that is not well controlled with antihypertensive medication (systolic blood pressure ≥ 160mm Hg or diastolic blood pressure ≥ 100mm Hg)
- New York heart association (NYHA) class III or IV congestive heart failure
- Alanine aminotransferase (ALT) ≥ 2×ULN, aspartate aminotransferase(AST) ≥ 2×ULN; Serum total bilirubin > 1.5×ULN;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pharmacokinetics of RAY1225 Following Administration to Subjects With Impaired Renal Function
The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.
- Conditions
- Kidney Impairment
- Being tested
- RAY1225
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RAY1225Drug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| RAY1225 - Mild Renal Impairment | Experimental | RAY1225 3mg administered SC to participants with mild renal impairment. Receives: Drug: RAY1225 |
| RAY1225 - Moderate Renal Impairment | Experimental | RAY1225 3mg administered SC to participants with moderate renal impairment. Receives: Drug: RAY1225 |
| RAY1225 - Severe Renal Impairment | Experimental | RAY1225 3mg administered SC to participants with severe renal impairment. Receives: Drug: RAY1225 |
| RAY1225 - Control | Experimental | RAY1225 3 milligrams (mg) administered subcutaneously (SC) to healthy participants with normal renal function. 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 posted26 Sep 2024
- Study start11 Sep 2024
- Primary completion10 Jan 2025
- Study completion20 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney ImpairmentStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
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
- NCT06613763
- Sponsor's protocol ID
- RAY1225-24-06
- Status last verified
- Sep 2024
- First submitted
- 23 Sep 2024
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of RAY1225 Following Administration to Subjects With Impaired Renal Function
- ClinicalTrials.gov ID
- NCT06613763
- Acronym / sponsor ID
- RAY1225-24-06
- Conditions
- Kidney Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 20 Jan 2025 (actual)
- First posted
- 26 Sep 2024 (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.
The purpose of this study is to assess how fast RAY1225 gets into the blood stream and how long it takes the body to remove it in participants with impaired kidney function compared to healthy participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| RAY1225 - Mild Renal Impairment | Experimental | Drug: RAY1225RAY1225 3mg administered SC to participants with mild renal impairment. |
| RAY1225 - Moderate Renal Impairment | Experimental | Drug: RAY1225RAY1225 3mg administered SC to participants with moderate renal impairment. |
| RAY1225 - Severe Renal Impairment | Experimental | Drug: RAY1225RAY1225 3mg administered SC to participants with severe renal impairment. |
| RAY1225 - Control | Experimental | Drug: RAY1225RAY1225 3 milligrams (mg) administered subcutaneously (SC) to healthy participants with normal renal function. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Body mass index (BMI) ≥18 to ≤28kg/m2 and total body weight >50 kg(male) or >40kg(female) at Screening (calculated as a function of measured height and weight according to the formula, BMI = kg / m2 where m2 is height in meters squared);
- Ability to understand and willingness to sign a written informed consent form;
- Normal physical examination, vital signs, 12-lead ECG, Chest X-ray images (anteroposterior) and clinical laboratory values, or any abnormality that is non-clinically significant；
- Glomerular filtration rate (GFR)≥ 90 mL/min and <130 mL/min ；
- Age, BMI, and sex comparable to those of subjects of renal impairment；
Key exclusion criteria (10 listed)
- Participants with an allergic disposition (multiple drug and food allergies) or who, have known allergies to RAY1225 or related compounds;
- Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
- Participants who donated blood or bleeding profusely (> 400 mL) in the 3 months or donated blood or bleeding profusely (> 200 mL) in the 1 months;
- Pregnant or lactating women, or women of childbearing age with a positive pregnancy test
- Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks
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 |
|---|---|---|
| RAY1225Administered SC | Drug | RAY1225 - Control, RAY1225 - Mild Renal Impairment, RAY1225 - Moderate Renal Impairment, RAY1225 - Severe Renal Impairment |
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
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 RAY1225 in people with Kidney Impairment, 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 8 inclusion and 10 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: finished, as of the sponsor's last update on 5 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 5 Mar 2025.