Hepatic ImpairmentPhase 1NCT06577415
A Study of RAY1225 in Participants With Impaired Liver Function
A Phase 1 study testing RAY1225 in people with Hepatic 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 liver 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
- Hepatic 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
- 24 participants
- Where
- 1 siteChina
- Study dates
- 26 Aug 2024to 15 Nov 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
- Participant must be ≥ 18 to ≤ 75 years;
- BMI ≥ 20 kg/m2 up to ≤ 32 kg/m2;
- Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product;
- Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment;
- eGFR ≥ 60 mL/min/1.73 m2;
- Participants with Normal Hepatic Function Only:
Show all 9Show fewer
- Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal liver function;
- Participants with hepatic impairment only:
- Males or females with chronic mild and moderate liver impairment, assessed by Child-Pugh scoring.
Who cannot join
- Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product;
- QTcF> 450ms;
- Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks;
- Participates who donated blood or bleeding profusely (> 400 mL) in the 3 months;
- Pregnant or lactating women, or women of childbearing age with a positive pregnancy test;
- Smoking averaged more than 10 cigarettes per day in the 3 months prior to screening;
Show all 12Show fewer
- Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2;
- Participants with Normal Hepatic Function Only:
- Any history of hepatic impairment, or potential presence of liver function impairment by physical examination and laboratory examination at screening.
- Participants with Hepatic Impairment Only:
- Any history of clinically serious illness or disease or condition except for primary liver disease that the investigator believes may affect the results of the trial, including but not limited to a history of circulatory, endocrine, nervous, digestive, urinary, respiratory or hematological, immune, psychiatric, and metabolic disorders.
- Participants with drug-induced liver injury; history of liver transplantation; cirrhosis in combination with the following complications: including but not limited to liver failure, hepatic encephalopathy, hepatocellular carcinoma, esophageal bleeding from ruptured fundic varices.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanfang Hospital,South Medical Hospital
Guangzhou, Guangdong
Zhongyuan XU
About this study
Official title: A Single Dose Pharmacokinetic Study of ray1225 in Subjects With Varying Degrees of Hepatic Impairment
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 liver function compared to healthy participants.
- Conditions
- Hepatic Impairment
- Being tested
- RAY1225
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 |
|---|---|---|
| Mild Hepatic Impairment | Experimental | Participants with mild hepatic impairment received single subcutaneous dose of 3 milligrams (mg) RAY1225. Receives: Drug: RAY1225 |
| Moderate Hepatic Impairment | Experimental | Participants with moderate hepatic impairment received single subcutaneous dose of 3 mg RAY1225. Receives: Drug: RAY1225 |
| Normal Hepatic Function | Active comparator | Participants with normal hepatic function received single subcutaneous dose of 3 mg RAY1225. 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 Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225.
Measured: DAY1~43
PK: Maximum Observed Drug Concentration (Cmax) of RAY1225
PK: Maximum Observed Drug Concentration (Cmax) of RAY1225
Measured: DAY1~43
Secondary outcomes (1)
Number of participants with drug-related adverse events as assessed by CTCAE v5.0
Measured: DAY1~43
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2024
- Study start26 Aug 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion15 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic 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
- 24 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
- NCT06577415
- Sponsor's protocol ID
- RAY1225-24-04
- Status last verified
- Aug 2024
- First submitted
- 27 Aug 2024
- Last updated
- 19 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 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Dose Pharmacokinetic Study of ray1225 in Subjects With Varying Degrees of Hepatic Impairment
- ClinicalTrials.gov ID
- NCT06577415
- Acronym / sponsor ID
- RAY1225-24-04
- Conditions
- Hepatic Impairment
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Guangdong Raynovent Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 15 Nov 2025 (estimated)
- First posted
- 29 Aug 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 liver 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild Hepatic Impairment | Experimental | Drug: RAY1225Participants with mild hepatic impairment received single subcutaneous dose of 3 milligrams (mg) RAY1225. |
| Moderate Hepatic Impairment | Experimental | Drug: RAY1225Participants with moderate hepatic impairment received single subcutaneous dose of 3 mg RAY1225. |
| Normal Hepatic Function | Active comparator | Drug: RAY1225Participants with normal hepatic function received single subcutaneous dose of 3 mg RAY1225. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Participant must be ≥ 18 to ≤ 75 years;
- BMI ≥ 20 kg/m2 up to ≤ 32 kg/m2;
- Participants (including partners) must use reliable methods of contraception during the study and until 6 months following the last dose of investigational product;
- Signature of a dated Informed Consent Form (ICF) indicating that the participates has been informed of all the relevant aspects(including adverse events) of the trial prior to enrollment;
- eGFR ≥ 60 mL/min/1.73 m2;
Key exclusion criteria (12 listed)
- Participants with an allergic disposition (multiple drug and food allergies) or who, as determined by the investigator, are likely to be allergic to the investigational drug product or any component of the investigational drug product;
- QTcF> 450ms;
- Participants with serious infections, trauma, gastrointestinal surgery or other major surgical procedures within 4 weeks;
- Participates who donated blood or bleeding profusely (> 400 mL) in the 3 months;
- Pregnant or lactating women, or women of childbearing age with a positive pregnancy test;
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 | Mild Hepatic Impairment, Moderate Hepatic Impairment, Normal Hepatic Function |
Primary outcome
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225
Time frame: DAY1~43
Pharmacokinetics (PK): Area Under The Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225.
PK: Maximum Observed Drug Concentration (Cmax) of RAY1225
Time frame: DAY1~43
PK: Maximum Observed Drug Concentration (Cmax) of RAY1225
1 secondary outcome
Number of participants with drug-related adverse events as assessed by CTCAE v5.0
Time frame: DAY1~43
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
Related trials for Hepatic Impairment
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
Not yet recruitingPhase 1
A Study of Zovaglutide (ZT002 Injection) in Participants With Hepatic Impairment and Healthy Participants
Overweight, Obesity
Not yet recruitingPhase 1
A Study to Investigate Safety, Tolerability, and Pharmacokinetics of Tacabrutideg (BGB-16673) in Participants With Moderate and Severe Hepatic Impairment
Hepatic Impairment, Healthy Adult Participants
RecruitingPhase 1
Investigation of Pharmacokinetics, Safety of HSK31858 in Subjects With Hepatic Impairment
Non-cystic Fibrosis Bronchiectasis (NCFBE)
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.
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 Hepatic 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 9 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 19 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhongyuan XU (020-62786845, nfyygcp@126.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 Drug Concentration-Time Curve From Zero To Infinity (AUC[0-∞]) of RAY1225 (time frame: DAY1~43). 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 19 Mar 2025.