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YN001 in Healthy Subjects and Patients With Coronary Atherosclerosis | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

YN001 in Healthy Subjects and Patients With Coronary Atherosclerosis

A Phase I/IIa Trial to Evaluate the Safety, Tolerability, PK, and Preliminary Efficacy of Single and Multiple Ascending Doses of YN001 in Healthy Subjects and Multiple Ascending Doses of YN001 in Patient With Coronary Atherosclerosis

NCT06048588•Beijing Inno Medicine Co., Ltd.

View on ClinicalTrials.gov

Summary

This study consists of two parts. The SAD and MAD of part I are a randomized, double-blind, placebo-controlled, single and multiple ascending dose study in healthy adult subjects. The MAD expansion cohort of part I is single arm and multipal ascending dose in heallthy subjects. Part II (phase Ib/IIa) is a multicenter, randomized, controlled, open label, multiple ascending dose study in patients with coronary atherosclerosis.

Detailed Description

Part I (phase Ia) is consists of 2 sections. The sections 1 is designed to evaluate the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of intravenously administered YN001, and to evaluate the effect of SAD of intravenously administered YN001 on the QT/QTc interval, and the immunogenicity of MAD of intravenously administered YN001 in healthy subjects. Besides, the section 2 is designed to evaluate the safety and tolerability of multiple intravenous administration of YN001 without pre-medication or with different pre-medication regimens in Chinese healthy subjects. Part II (phase Ib/IIa) is designed to evaluate the safety, tolerability, pharmacokinetics, preliminary efficacy, immunogenicity, and the effect on cytokine changes of MAD of intravenously administered YN001 in patients with coronary atherosclerosis.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•1. Fully understand the purposes, features, and methods of the study and the possible adverse reactions, voluntarily participate in the study as a subject, and sign the ICF before performing any assessment.
•2. Chinese healthy male or female subjects between 18 and 55 years.
•3. A Body Mass Index (BMI) of 18-28 kg/m2 (inclusive), with a body weight of at least 50 kg for males and 45 kg for females.
•4. Be in good general health at discretion of the investigator based on the results (be normal or abnormal without clinical significance) of medical history, physical examination, vital signs,12-lead ECG, laboratory tests (Hematology; Blood chemistry; Urinalysis, Coagulation and CRP) and viral serology.
•5. Female subjects must be non-pregnant and non-lactating, and women of childbearing potential (including the male subject's female companion) must agree to use effective method of contraception from the screening period to 3 months after receiving their last dose of the investigational drug.
•6. Willing and able to comply with the requirements of protocol.
•1. Fully understand the purposes, features, and methods of the study and the possible adverse reactions, voluntarily participate in the study as a subject, and sign the ICF before performing any assessment.
•2. Chinese male or female subjects between 18 and 75 years.
•3. Patients diagnosed with confirmed coronary atherosclerosis and 25-75% stenosis determined by coronary angiography.
•4. Suspicion of vulnerable plaque based on clinical practice and determined by OCT examination.
+3 more criteria

Exclusion Criteria

•1. Prior treatment with other investigational drug(s) within 3 months or 5 half-lives, whichever is longer, prior to the first dosing.
•2. Prior treatment with any prescription drugs, herbal supplements, over the counter (OTC) medication, dietary supplements (vitamins included), or any type of vaccination within 2 weeks prior to the first dosing.
•3. Presenting with history of severe food allergy (e.g., anaphylactic reaction). Mild (e.g., non-anaphylactic, hypersensitivity) food allergies such as lactose intolerance/ glucose intolerance are permitted.
•4. Allergy to multiple kinds of drugs or presenting with history of allergic reactions to any components of the study drug.
•5. Known any clinically abnormal diseases or factors, including but not limited to neurological, cardiovascular, hematological, hepatic, renal, gastrointestinal, respiratory, metabolic, endocrine, immunological, skeletal system diseases, or other reasons that, in the opinion of the investigator, makes the subject inappropriate for inclusion in this study.
•6. Presenting with history of myopathy/ myalgia, or susceptible to myopathy/ rhabdomyolysis.
•7. Presence of hypothyroidism.
•8. Presenting and/or relapse history (within the last 3 years) of acute or chronic bronchospastic disease (including asthma and chronic obstructive pulmonary disease, treated, or not treated) or cardiac dysfunction or myocardial infarction.
•9. Known inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding within 6 months prior to the first dosing.
•10. Presenting with history of pancreatic injury or pancreatitis within 6 months prior to the first dosing.
+39 more criteria

Locations (6)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Peking University first hospital

Beijing, Beijing Municipality, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

First Hospital of Jilin University

Changchun, Jilin, China

Renji Hospital Shanghai Jiaotong Unv. school of Medicine

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

October 8, 2023

Primary Completion Date

April 27, 2025

Completion Date

April 27, 2025

Last Updated

April 30, 2025

Enrollment

144

ACTUAL participants

Conditions

Atherosclerotic Cardiovascular Disease

Interventions

YN001

DRUG

Placebo for YN001

DRUG

rosuvastatin calcium tablets

DRUG

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Atherosclerotic Cardiovascular Disease (ASCVD)

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RECRUITING

A Study Assessing Repatha® in Combination With Standard of Care (SOC) Compared With SOC on Major Cardiovascular Events in Chinese Participants With Atherosclerotic Cardiovascular Disease

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Major Cardiovascular EventEstablished Atherosclerotic Cardiovascular Disease

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 30, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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YN001 in Healthy Subjects and Patients With Coronary Atherosclerosis

Inclusion Criteria

Exclusion Criteria

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