Phase 1 Study of the Safety and Pharmacokinetics of YN001 With Rosuvastatin in Healthy Chinese Subjects

NCT07309042 | Not Yet Recruiting Phase 1

• 1 other identifier: YN001-105
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Atherosclerotic Cardiovascular Diseases; Cerebrovascular Diseases

Outcome Measures

Primary Outcomes (1)

• The incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)

  84 days

Secondary Outcomes (2)

• Plasma pharmacokinetics: Maximum plasma concentration (Cmax)

  63 days

• Number of Participants With ADA

  63 days

Study Arms (3)

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

Interventions

YN001, Rosuvastatin calcium Tablets DRUG

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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).

Sponsors & Collaborators

• Beijing Inno Medicine Co., Ltd.: lead

MeSH Terms

Conditions

Cerebrovascular Disorders

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Teresa Chen, Master

  Beijing Inno Medicine Co., Ltd.

  STUDY DIRECTOR

Central Study Contacts

Jean Zhang

CONTACT

861082599080; zhangjing@innovmedicine.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 30, 2025
• Study Start: December 1, 2025
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 30, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share