Atherosclerotic Cardiovascular DiseasesPhase 1NCT07309042
Phase 1 Study of the Safety and Pharmacokinetics of YN001 With Rosuvastatin in Healthy Chinese Subjects
A Phase 1 study testing YN001, Rosuvastatin calcium Tablets in people with Atherosclerotic Cardiovascular Diseases and Cerebrovascular Diseases, run by Beijing Inno Medicine Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this study is to investigate the safety and tolerability of YN001 in combination with rosuvastatin, so as to provide evidence for the feasibility of YN001 combined with statins in subsequent clinical trials. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Atherosclerotic Cardiovascular Diseases, Cerebrovascular Diseases
- What is being tested?
- YN001, Rosuvastatin calcium Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 8 Dec 2025to 30 Mar 2026
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fully understand the purpose, characteristics, research methods and potential adverse reactions of this study, voluntarily participate in the study as a subject, and sign the Informed Consent Form (ICF) before any assessments are performed.
- Healthy Chinese male and female subjects aged 18 to 55 years (inclusive, based on the age at the time of signing the ICF).
- Body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) ranging from 18 to 28 kg/m² (including the critical values).
- Judged by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function) and viral serological test results (normal or abnormal without clinical significance) to be in good general health.
- Female subjects must be non-pregnant and non-lactating; female subjects of childbearing potential (including female partners of male subjects) must agree to use effective contraceptive methods such as abstinence, condoms, intrauterine devices in use, double barrier methods (e.g., condoms plus diaphragms) from the screening period until 6 months after receiving the last dose of the study drug.
- Willing and able to comply with the requirements of the study protocol.
Who cannot join
- Participation in other clinical trials within 3 months prior to the first dose or within 5 half-lives (whichever is longer). Subjects who withdrew from the study before receiving the study drug (i.e., not administered the drug) are eligible for enrollment.
- Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health supplements within 2 weeks prior to the first dose, or receipt of any type of vaccination.
- Consumption of diets that may affect the in vivo metabolism of drugs (including grapefruit or grapefruit products, pitaya, mango, etc.) within 7 days prior to screening, engagement in strenuous exercise, or consumption of other diets that the investigator deems may affect the absorption, distribution, metabolism, or excretion of drugs.
- History of severe food allergies (e.g., anaphylactic shock). Mild food allergies such as lactose intolerance and glucose intolerance are not excluded.
- Allergy to multiple drugs, history of allergy to rosuvastatin, or history of allergic reactions to any component of the study drugs.
- Known presence of clinically significant abnormal diseases or factors, including but not limited to clinically significant abnormalities in abdominal color Doppler ultrasound (liver, gallbladder, spleen, pancreas, bilateral kidneys, ureters, urinary bladder), chest posteroanterior radiography, etc.; or clinically significant diseases (including but not limited to diseases of the digestive system, circulatory system, respiratory system, endocrine system, urinary system, immune system, nervous system, and mental and psychological diseases) shown by other clinical findings within 6 months prior to screening.
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- History of myopathy/myalgia, or predisposition to myopathy/rhabdomyolysis (e.g., family history of hereditary myopathy, previous combined use of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitors and fibrates, etc.).
- Presence of hypothyroidism or hyperthyroidism.
- History of acute or chronic bronchospastic diseases (including asthma, chronic obstructive pulmonary disease, whether treated or not) or heart failure, myocardial infarction, with a history of onset or recurrence within the past 3 years.
- Known history of inflammatory bowel disease, ulcers, gastrointestinal bleeding, or rectal bleeding within 6 months prior to the first dose.
- History of pancreatic injury or pancreatitis within 6 months prior to dosing.
- Presence of symptoms of urinary tract obstruction or dysuria.
- History of autonomic nervous system disorders (e.g., recurrent syncope, palpitations, etc.), with a history of onset or recurrence within the past 3 years.
- Suffering from a major unhealed disease within 2 weeks prior to the first dose; or expected to undergo major surgery during the study period.
- History of renal impairment, manifested by clinically significant abnormalities in creatinine, blood urea nitrogen (BUN) and/or urea levels, or clinically significant abnormalities in urine components (e.g., proteinuria).
- Presence of liver disease or liver injury, or abnormal liver function test results. Subjects who meet any of the following criteria must be excluded from the study:
- Any one of alanine aminotransferase (ALT), aspartate aminotransferase (AST), or serum bilirubin exceeds 1.5 times the upper limit of normal (ULN).
- Any two or more of ALT, AST, or serum bilirubin exceed the upper limit of normal (ULN).
- History of clinically significant electrocardiogram (ECG) abnormalities; or presence of any of the following abnormalities during screening or baseline period:
- QTcF (males) > 470 milliseconds (msec).
- QTcF (females) > 480 milliseconds (msec). (Corrected by the Frederica formula, calculated as QTcF = QT/(RR⁰·³³))
- Screening test shows hemoglobin level < 120 grams per liter (g/L) in males and < 110 grams per liter (g/L) in females.
- Blood donation or blood loss exceeding 400 milliliters (mL) within 3 months prior to screening.
- Smoking more than 10 cigarettes per day or habitual use of nicotine-containing products within 3 months prior to screening.
- History of drug abuse within 12 months prior to screening; or use of any illegal drugs within 3 months prior to screening; or positive results in drug abuse tests (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, morphine, etc.) during screening.
- Weekly alcohol consumption exceeding 14 standard drinking units (1 standard drinking unit = 285 mL of beer, or 25 mL of spirits, or 150 mL of wine) within 3 months prior to screening; or consumption of alcohol-containing products within 48 hours prior to the first dose; or positive results in breath alcohol test during the baseline period.
- Positive results in tests for hepatitis B surface antigen (HBsAg), hepatitis C virus (HCV) antibody, human immunodeficiency virus (HIV) antibody, or Treponema pallidum antibody.
- The investigator deems the subject unsuitable for participation in the study due to any other diseases or conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Open-label Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of the Combination of YN001 and Oral Rosuvastatin Calcium Tablets in Healthy Chinese Individuals
The primary objective of this study is to investigate the safety and tolerability of YN001 in combination with rosuvastatin, so as to provide evidence for the feasibility of YN001 combined with statins in subsequent clinical trials.
Read the detailed description
The primary objective of this study is to generate the evidence on the safety, tolerability and pharmacokinetic (PK) interaction profile of YN001 when combined with rosuvastatin, a widely prescribed high-intensity statin.
YN001 is being developed for patients with atherosclerotic cardiovascular disease (ASCVD) or at high cardiovascular risk. In these populations, contemporary treatment guidelines recommend statin therapy as foundational background treatment. However, because the human safety and PK profile of YN001 in combination with statins have not yet been established, concomitant statin use has been prohibited in all completed, ongoing, and planned YN001 clinical trials. This restriction creates a clinically and regulatorily important evidence gap: for YN001 to be used in its intended population, it is essential to determine whether co-administration with rosuvastatin is safe and whether either drug's systemic exposure is meaningfully altered.
To address this gap, the present study is designed as a single-centre, randomised, open-label, 3-sequence, 3-period crossover trial in healthy volunteers. The study will evaluate the the safety, tolerability and pharmacokinetics of repeated-dose intravenous YN001 administered alone and in combination with oral rosuvastatin calcium.
A total of 24 subjects will be enrolled. After screening, eligible participants will be randomly allocated 1:1:1 to three cohorts (8 per cohort, target 1:1 sex ratio). Each cohort will undergo three 14-day treatment periods separated by a 7-day wash-out (permissible window ±7 days).
The results of this study will inform whether concomitant statin can be safely permitted in subsequent Phase II and Phase III YN001 clinical trials, thereby enabling evaluation of YN001 in the intended ASCVD and high-cardiovascular-risk populations for whom chronic statin therapy is standard of care.
- Being tested
- YN001, Rosuvastatin calcium Tablets
- Medical subject headings
- Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YN001, Rosuvastatin calcium TabletsDrug
Cycle 1 (Day 1 to day 14) : YN001, 40 mg, once a week, intravenous infusion, administered on day 1 and day 8, for a total of 2 doses. Cycle 2 (days 22 to 35) : YN001, 40 mg, once a week, intravenous infusion, administration on days 22 and 29, for a total of two doses. Rosuvastatin calcium Tablets, 10 mg, once a night, orally. Cycle 3 (Days 43 to 56) : Rosuvastatin calcium Tablets, 10 mg, once a night, orally.
YN001, Rosuvastatin calcium TabletsDrug
Cycle 1 (Day 1 to day 14) : YN001, 40 mg, once a week, intravenous infusion, administered on day 1 and day 8, for a total of two doses. Rosuvastatin calcium Tablets, 10 mg, once a night, oral administration. Cycle 2 (Days 22 to 35) : Rosuvastatin calcium Tablets, 10 mg, once a night, orally. Cycle 3 (days 43 to 56) : YN001, 40 mg, once a week, intravenous infusion, administration of D43 and D50, for a total of two doses.
YN001, Rosuvastatin calcium TabletsDrug
Cycle 1 (Day 1 to day 14) : Rosuvastatin calcium Tablets, 10 mg, once a night, orally. Cycle 2 (Days 22 to 35) : YN001, 40 mg, once a week, intravenous infusion. Cycle 3 (days 43 to 56) : YN001, 40 mg, once a week, intravenous infusion, administration of D43 and D50, for a total of two doses. Rosuvastatin calcium Tablets, 10 mg, once a night, oral administration.
| Study group | Role | What they receive |
|---|---|---|
| YN001 | Other | Not described Receives: Drug: YN001, Rosuvastatin calcium Tablets |
| YN001+ Rosuvastatin calcium Tablets | Other | Not described Receives: Drug: YN001, Rosuvastatin calcium Tablets |
| Rosuvastatin calcium Tablets | Other | Not described Receives: Drug: YN001, Rosuvastatin calcium Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 84 days
Secondary outcomes (2)
Plasma pharmacokinetics: Maximum plasma concentration (Cmax)
Measured: 63 days
Number of Participants With ADA
Measured: 63 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start8 Dec 2025
- Primary completion30 Mar 2026
- Study completion30 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseasesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Inno Medicine Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teresa Chen, Master, Study director, Beijing Inno Medicine Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07309042
- Sponsor's protocol ID
- YN001-105
- Status last verified
- Sep 2026
- First submitted
- 27 Nov 2025
- Last updated
- 23 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 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label Phase 1 Clinical Trial to Evaluate the Safety and Pharmacokinetic Characteristics of the Combination of YN001 and Oral Rosuvastatin Calcium Tablets in Healthy Chinese Individuals
- ClinicalTrials.gov ID
- NCT07309042
- Acronym / sponsor ID
- YN001-105
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Beijing Inno Medicine Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- 30 Mar 2026 (actual)
- Study completion
- 30 Mar 2026 (actual)
- First posted
- 30 Dec 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.
The primary objective of this study is to investigate the safety and tolerability of YN001 in combination with rosuvastatin, so as to provide evidence for the feasibility of YN001 combined with statins in subsequent clinical trials.
Detailed description
The primary objective of this study is to generate the evidence on the safety, tolerability and pharmacokinetic (PK) interaction profile of YN001 when combined with rosuvastatin, a widely prescribed high-intensity statin.
YN001 is being developed for patients with atherosclerotic cardiovascular disease (ASCVD) or at high cardiovascular risk. In these populations, contemporary treatment guidelines recommend statin therapy as foundational background treatment. However, because the human safety and PK profile of YN001 in combination with statins have not yet been established, concomitant statin use has been prohibited in all completed, ongoing, and planned YN001 clinical trials. This restriction creates a clinically and regulatorily important evidence gap: for YN001 to be used in its intended population, it is essential to determine whether co-administration with rosuvastatin is safe and whether either drug's systemic exposure is meaningfully altered.
To address this gap, the present study is designed as a single-centre, randomised, open-label, 3-sequence, 3-period crossover trial in healthy volunteers. The study will evaluate the the safety, tolerability and pharmacokinetics of repeated-dose intravenous YN001 administered alone and in combination with oral rosuvastatin calcium.
A total of 24 subjects will be enrolled. After screening, eligible participants will be randomly allocated 1:1:1 to three cohorts (8 per cohort, target 1:1 sex ratio). Each cohort will undergo three 14-day treatment periods separated by a 7-day wash-out (permissible window ±7 days).
The results of this study will inform whether concomitant statin can be safely permitted in subsequent Phase II and Phase III YN001 clinical trials, thereby enabling evaluation of YN001 in the intended ASCVD and high-cardiovascular-risk populations for whom chronic statin therapy is standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| YN001 | Other | Drug: YN001, Rosuvastatin calcium Tablets |
| YN001+ Rosuvastatin calcium Tablets | Other | Drug: YN001, Rosuvastatin calcium Tablets |
| Rosuvastatin calcium Tablets | Other | Drug: YN001, Rosuvastatin calcium Tablets |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Fully understand the purpose, characteristics, research methods and potential adverse reactions of this study, voluntarily participate in the study as a subject, and sign the Informed Consent Form (ICF) before any assessments are performed.
- Healthy Chinese male and female subjects aged 18 to 55 years (inclusive, based on the age at the time of signing the ICF).
- Body weight ≥ 50 kg for males and ≥ 45 kg for females; body mass index (BMI) ranging from 18 to 28 kg/m² (including the critical values).
- Judged by the investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function) and viral serological test results (normal or abnormal without clinical significance) to be in good general health.
- Female subjects must be non-pregnant and non-lactating; female subjects of childbearing potential (including female partners of male subjects) must agree to use effective contraceptive methods such as abstinence, condoms, intrauterine devices in use, double barrier methods (e.g., condoms plus diaphragms) from the screening period until 6 months after receiving the last dose of the study drug.
Key exclusion criteria (28 listed)
- Participation in other clinical trials within 3 months prior to the first dose or within 5 half-lives (whichever is longer). Subjects who withdrew from the study before receiving the study drug (i.e., not administered the drug) are eligible for enrollment.
- Use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines, or health supplements within 2 weeks prior to the first dose, or receipt of any type of vaccination.
- Consumption of diets that may affect the in vivo metabolism of drugs (including grapefruit or grapefruit products, pitaya, mango, etc.) within 7 days prior to screening, engagement in strenuous exercise, or consumption of other diets that the investigator deems may affect the absorption, distribution, metabolism, or excretion of drugs.
- History of severe food allergies (e.g., anaphylactic shock). Mild food allergies such as lactose intolerance and glucose intolerance are not excluded.
- Allergy to multiple drugs, history of allergy to rosuvastatin, or history of allergic reactions to any component of the study drugs.
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 |
|---|---|---|
| YN001, Rosuvastatin calcium TabletsCycle 1 (Day 1 to day 14) : YN001, 40 mg, once a week, intravenous infusion, administered on day 1 and day 8, for a total of 2 doses. Cycle 2 (days 22 to 35) : YN001, 40 mg, once a week, intravenous infusion, administration on days 22 and 29, for a total of two doses. Rosuvastatin calcium Tablets, 10 mg, once a night, orally. Cycle 3 (Days 43 to 56) : Rosuvastatin calcium Tablets, 10 mg, once a night, orally. | Drug | YN001 |
| YN001, Rosuvastatin calcium TabletsCycle 1 (Day 1 to day 14) : YN001, 40 mg, once a week, intravenous infusion, administered on day 1 and day 8, for a total of two doses. Rosuvastatin calcium Tablets, 10 mg, once a night, oral administration. Cycle 2 (Days 22 to 35) : Rosuvastatin calcium Tablets, 10 mg, once a night, orally. Cycle 3 (days 43 to 56) : YN001, 40 mg, once a week, intravenous infusion, administration of D43 and D50, for a total of two doses. | Drug | YN001+ Rosuvastatin calcium Tablets |
| YN001, Rosuvastatin calcium TabletsCycle 1 (Day 1 to day 14) : Rosuvastatin calcium Tablets, 10 mg, once a night, orally. Cycle 2 (Days 22 to 35) : YN001, 40 mg, once a week, intravenous infusion. Cycle 3 (days 43 to 56) : YN001, 40 mg, once a week, intravenous infusion, administration of D43 and D50, for a total of two doses. Rosuvastatin calcium Tablets, 10 mg, once a night, oral administration. | Drug | Rosuvastatin calcium Tablets |
Primary outcome
The incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 84 days
2 secondary outcomes
Plasma pharmacokinetics: Maximum plasma concentration (Cmax)
Time frame: 63 days
Number of Participants With ADA
Time frame: 63 days
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 23 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. This study is not recruiting at the moment.
Teresa Chen, Master study director
Beijing Inno Medicine Co., Ltd.
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 YN001, Rosuvastatin calcium Tablets in people with Atherosclerotic Cardiovascular Diseases and Cerebrovascular Diseases, run by Beijing Inno Medicine 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 6 inclusion and 28 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 23 Sep 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?
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?
The incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 84 days). 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 23 Sep 2026.