Renal InsufficiencyPhase 1NCT07001436
A Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects
A Phase 1 study testing Azvudine tablets in people with Renal Insufficiency, run by Henan Genuine Biotech Co., Ltd. at 1 site in China.
Trial summary
Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Azvudine tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2025to 30 Sep 2025
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- (一) Renal insufficiency study participants and healthy study participants:
- Age ≥ 18 years old and ≤ 70 years old, regardless of gender;
- Body mass index (BMI) within the range of 18.0-30.0 (including the critical value) (BMI = weight (kg) / height 2 (m2)), the weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg;
- Females of childbearing potential must have taken reliable and highly effective contraceptive measures and have a negative baseline blood pregnancy test at screening, and are willing to use appropriate and efficient methods of contraception after signing the informed consent form until 3 months after the last dose of the test drug; Male study participants who are willing to do so for the duration of the trial and for 3 months after the last dose of the trial drug Have no plans to have children and voluntarily use highly effective contraception, or have been surgically sterilized;
- Understand and sign the informed consent form.
- (二) Health study participants (in addition to the above criteria, they should also meet):
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- The health condition is judged by the investigator to be good, and the results of vital signs, physical examination, electrocardiogram, and laboratory examination are normal or abnormal, and there is no clinical significance;
- Those who have not taken any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health care products within 14 days before screening;
- Meet the classification standard of glomerular filtration rate of 90≤GFR<130 ml/min;
- Study participants with mild or moderate decline in GFR were matched with the following demographic characteristics: age (mean ± 10 years), weight (mean ±10kg), and gender (±1 cases).
- (三) Renal insufficiency study participants (in addition to the above criteria, they should also meet):
- Stable renal function status: the existing renal function impairment is required to last for more than 3 months, and the GFR results of two tests (with an interval of 72 hours or more) during the screening period are within the same grade and the difference between the two tests is not more than 25%;
- No clinically significant abnormalities were found in the pre-test medical history, vital signs, physical examination, laboratory test items (except ALT and AST, total bilirubin, and direct bilirubin) and test-related examinations and were judged by the clinical research physician to be eligible for enrollment (except for abnormalities related to renal impairment);
- The drug being taken by the study participant with renal insufficiency, which should not affect the absorption, distribution, metabolism or excretion of the study drug, and has been taken at a stable dose for at least 4 consecutive weeks before giving the study drug, and agrees to continue treatment during the study period;
- Two weeks before administration and during the test, Chinese patent medicines, traditional Chinese medicine decoctions, ethnic medicines, SGLT-2i, MRA drugs and benzbromarone are prohibited;
- During the screening period, it is necessary to meet: alanine aminotransferase (ALT), aspartate aminotransferase (AST), total bilirubin (TBIL), and direct bilirubin (DBIL) all need to < 1.5 upper limit of normal (ULN)
- Participants in the study of renal insufficiency of all grades met the grading criteria for glomerular filtration rate (GFR was taken as the average of the two tests during the screening period): Mild decrease in GFR: 60≤ GFR≤89 ml/min; Moderate decrease in GFR: 30≤GFR ≤59 ml/min.
Who cannot join
- (一) Renal insufficiency and health research participants:
- Allergies, especially those who are allergic to any of the ingredients in this product and excipients;
- Those who have undergone gastrointestinal resection in the past, or suffer from digestive diseases that will affect the absorption, distribution, metabolism and excretion of drugs;
- Those who have a history of drug abuse within 12 months before screening or those who have tested positive for addictive substances before enrollment;
- Those with fever or infectious diseases at the time of screening;
- Those who have participated in other clinical trials within 3 months before screening;
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- Those who have a history of smoking addiction within 12 months before screening (the average number of cigarettes per day ≥5);
- Those who have a history of alcohol abuse within 12 months before screening (drinking ≥ 14 units of alcohol per week: 1 unit = 285mL of beer, or 25mL of spirits, or 150mL of wine) or positive alcohol breath test (test value >0mg/100mL) before enrollment;
- Those who have lost blood or donated 200mL of blood ≥ within 8 weeks before screening;
- Hepatitis B surface antigen, hepatitis C virus antibody, human immunodeficiency virus antibody, treponema pallidum antibody or rapid plasma reagin ring card test (RPR) test results are positive.
- Pregnant and lactating women;
- Those who cannot tolerate vascular puncture blood collection and/or have a history of blood sickness, needle fainting and/or poor blood collection vascular conditions;
- Those who have been vaccinated within 3 months before screening, or plan to be vaccinated during the trial;
- Those who are not considered suitable to enter this trial by the investigator.
- (二) Renal insufficiency study participants (except for the above criteria):
- Have undergone kidney transplantation;
- Systolic blood pressure outside the range of 90 ~ 160mmHg, diastolic blood pressure outside the range of 50 ~ 100mmHg, or heart rate outside the range of 50 ~ 120bpm;
- Frequent occurrence of hypoglycemia and exclusion of drug factors within 3 months prior to screening;
- Albumin<30g/L;
- Hemoglobin value<9 g/dL;
- Those who have a history of uncontrolled or unstable serious diseases of cardiovascular, liver, pulmonary, digestive tract, nerves, autoimmune, metabolic and musculoskeletal systems, hematopoietic systems and other systems, or those whose diseases are active.
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, 1 recruiting
- Recruiting
Beijing Jishuitan Hospital
Beijing, Beijing Municipality
Wang Meixia, +8613811117487, wangmeixiad@163.com
About this study
Official title: A Non-randomized, Open, Parallel, Single-dose Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects
Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase.
This trial uses a non-randomized, open-label, parallel, single-dose adaptive design aimed at investigating the effects of varying degrees of renal insufficiency on the pharmacokinetics, safety, and tolerability of a single oral dose of 3 mg Azvudine tablets in humans. On the first day of the study, a single oral dose of 3 mg ( 3 tablets ) of Azvudine tablets is taken orally on an empty stomach. Biological sample collection and safety examination will be performed in this trial.
- Conditions
- Renal Insufficiency
- Being tested
- Azvudine tablets
- Keywords
- Azvudine
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azvudine tabletsDrug
On the first day of the study, a single oral dose of 3 mg ( 3 tablets ) of Azvudine tablets is taken orally on an empty stomach.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 : subjects with mildly decreased GFR(GRF, Glomerular Filtration Rate) | Experimental | Not described Receives: Drug: Azvudine tablets |
| Group 2 : subjects with a moderate decrease in GFR | Experimental | Not described Receives: Drug: Azvudine tablets |
| Group 3 : healthy subjects matched with group 1 and group 2 | Experimental | Not described Receives: Drug: Azvudine tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Azvudine
Cmax will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
Measured: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from the First Dose to the Last Blood Collection Point (AUC0-t) of Azvudine
AUC0-t will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
Measured: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
Pharmacokinetics (PK): Area Under the Concentration-Time Curve Extrapolated from the Initial Administration to Infinity (AUC0-∞) of Azvudine (if applicable)
AUC0-∞ will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
Measured: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
Secondary outcomes (3)
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Azvudine
Tmax will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
Measured: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
Pharmacokinetics (PK): Elimination Half-life (t1/2) of Azvudine
t1/2 will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
Measured: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
Occurrence of Adverse Events
Clinical presentation characteristics, severity, onset time, duration of adverse events, management measures, outcomes, and the correlation with the investigational drug.
Measured: From enrollment to the end of the study on Day 4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2025
- Study start20 May 2025
- Primary completion30 Aug 2025 (estimated)
- Study completion30 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07001436
- Sponsor's protocol ID
- CR-FNC-RI-102
- Status last verified
- Apr 2025
- First submitted
- 23 May 2025
- Last updated
- 3 Jun 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 3 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Non-randomized, Open, Parallel, Single-dose Pharmacokinetics and Safety Study of Azvudine Tablets in Subjects With Mild-To-Moderate GFR Decline in Renal Insufficiency and in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07001436
- Acronym / sponsor ID
- CR-FNC-RI-102
- Conditions
- Renal Insufficiency
- Keywords
- Azvudine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Henan Genuine Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 May 2025 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 30 Sep 2025 (estimated)
- First posted
- 3 Jun 2025 (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.
Azvudine(FNC)，a nucleoside reverse transcriptase inhibitor, make itself a better candidate to be co-formulated in other anti-HIV therapies, thus to improve patient's compliance. FNC is a broad-spectrum RNA virus inhibitor that inhibits the novel coronavirus RNA-dependent RNA polymerase.
This trial uses a non-randomized, open-label, parallel, single-dose adaptive design aimed at investigating the effects of varying degrees of renal insufficiency on the pharmacokinetics, safety, and tolerability of a single oral dose of 3 mg Azvudine tablets in humans. On the first day of the study, a single oral dose of 3 mg ( 3 tablets ) of Azvudine tablets is taken orally on an empty stomach. Biological sample collection and safety examination will be performed in this trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group 1 : subjects with mildly decreased GFR(GRF, Glomerular Filtration Rate) | Experimental | Drug: Azvudine tablets |
| Group 2 : subjects with a moderate decrease in GFR | Experimental | Drug: Azvudine tablets |
| Group 3 : healthy subjects matched with group 1 and group 2 | Experimental | Drug: Azvudine tablets |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Age ≥ 18 years old and ≤ 70 years old, regardless of gender;
- Body mass index (BMI) within the range of 18.0-30.0 (including the critical value) (BMI = weight (kg) / height 2 (m2)), the weight of men should be ≥ 50.0kg, and the weight of women should be ≥ 45.0kg;
- Females of childbearing potential must have taken reliable and highly effective contraceptive measures and have a negative baseline blood pregnancy test at screening, and are willing to use appropriate and efficient methods of contraception after signing the informed consent form until 3 months after the last dose of the test drug; Male study participants who are willing to do so for the duration of the trial and for 3 months after the last dose of the trial drug Have no plans to have children and voluntarily use highly effective contraception, or have been surgically sterilized;
- Understand and sign the informed consent form.
- The health condition is judged by the investigator to be good, and the results of vital signs, physical examination, electrocardiogram, and laboratory examination are normal or abnormal, and there is no clinical significance;
Key exclusion criteria (21 listed)
- Allergies, especially those who are allergic to any of the ingredients in this product and excipients;
- Those who have undergone gastrointestinal resection in the past, or suffer from digestive diseases that will affect the absorption, distribution, metabolism and excretion of drugs;
- Those who have a history of drug abuse within 12 months before screening or those who have tested positive for addictive substances before enrollment;
- Those with fever or infectious diseases at the time of screening;
- Those who have participated in other clinical trials within 3 months before screening;
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 |
|---|---|---|
| Azvudine tabletsOn the first day of the study, a single oral dose of 3 mg ( 3 tablets ) of Azvudine tablets is taken orally on an empty stomach. | Drug | Group 1 : subjects with mildly decreased GFR(GRF, Glomerular Filtration Rate), Group 2 : subjects with a moderate decrease in GFR, Group 3 : healthy subjects matched with group 1 and group 2 |
Primary outcome
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Azvudine
Time frame: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
Cmax will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve from the First Dose to the Last Blood Collection Point (AUC0-t) of Azvudine
Time frame: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
AUC0-t will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
Pharmacokinetics (PK): Area Under the Concentration-Time Curve Extrapolated from the Initial Administration to Infinity (AUC0-∞) of Azvudine (if applicable)
Time frame: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
AUC0-∞ will be calculated by measuring the concentration of Azvudine in blood samples and urine samples.
3 secondary outcomes
Pharmacokinetics (PK): Time to Maximum Concentration (Tmax) of Azvudine
Time frame: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
Pharmacokinetics (PK): Elimination Half-life (t1/2) of Azvudine
Time frame: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose
Occurrence of Adverse Events
Time frame: From enrollment to the end of the study on Day 4.
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 3 Jun 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.
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 Azvudine tablets in people with Renal Insufficiency, run by Henan Genuine 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 17 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 3 Jun 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Azvudine (time frame: Blood samples: up to 48 hours post-dose; urine samples：up to 72 hours post-dose). The study lists 3 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 3 Jun 2025.