YN001 in Healthy Subjects and Patients With Coronary Atherosclerosis

NCT06048588 | Completed Phase 1

• 1 other identifier: YN001-002
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Atherosclerotic Cardiovascular Disease

Outcome Measures

Primary Outcomes (6)

• Part I: The safety and tolerability of YN001 in healthy subjects.

  To evaluate the incidence of Adverse Events as Assessed by CTCAE v5.0, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities, Clinically Significant Physical Examination Abnormalities.

  Up to 29 days

• Part I: Maximum plasma concentration(Cmax) of YN001

  To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects

  Up to 168 hours of post initiation of last dose

• Part I: Time of maximum concentration (Tmax) of YN001

  To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.

  Up to 168 hours of post initiation of last dose

• Part I: Elimination half-life (t1/2) of YN001

  To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.

  Up to 168 hours of post initiation of last dose

• Part I: Area under the plasma concentration-time curve from time 0 to the collection time point of the last measurable concentration (AUC0-t) of YN001

  To evaluate the pharmacokinetics (PK) characteristics of of intravenously administered YN001 in healthy subjects.

  Up to 168 hours of post initiation of last dose

• Part II: The safety and tolerability of intravenously administered YN001 in patients with coronary atherosclerosis.

  To evaluate the incidence of Adverse Events as Assessed by CTCAE v5.0, Clinically Significant Laboratory Abnormalities, Clinically Significant Electrocardiogram Abnormalities, Clinically Significant Vital Signs Abnormalities, Clinically Significant Physical Examination Abnormalities, Clinically Significant Echocardiogram Abnormalities.

  Up to 29 days

Secondary Outcomes (18)

• Part I: C-QTc analysis

  Pre-dose and up to 48 hours post initiation of infusion

• Part I: Immunogenicity analysis

  Up to 96 hours of post initiation of last dose

• Part I: Pharmacodynamic evaluation

  Up to 96 hours of post initiation of last dose

• Part II: Maximum plasma concentration(Cmax) of YN001

  Up to 96 hours of post initiation of last dose

• Part II: Time of maximum concentration (Tmax) of YN001

  Up to 96 hours of post initiation of last dose

Study Arms (3)

YN001

EXPERIMENTAL

YN001 will be administrated intravenous by single ascending dose, multiple ascending doses weekly or twice a week.

Drug: YN001

Part I-Matching placebo for YN001

PLACEBO COMPARATOR

Matching placebo for YN001 will be administrated intravenous.

Drug: Placebo for YN001

Part II-Rosuvastatin calcium tablets

ACTIVE COMPARATOR

Rosuvastatin calcium tablets will be given by orally.

Drug: rosuvastatin calcium tablets

Interventions

YN001 DRUG

In single ascending dose (SAD) part of study in health subjects, YN001 will be administrated one time with dosage from 10 mg to 120 mg (planned). In multiple ascending doses (MAD) part of study in health subjects, YN001 will be given twice a week from 5 mg to 40 mg up to 15 days. In MAD part of study in patients with coronary atherosclerosis, YN001 will be injected weekly or twice a week from 5mg to 40mg up to 85 days.

YN001

Placebo for YN001 DRUG

The injection solution to mimic the YN001

Also known as: Placebo

Part I-Matching placebo for YN001

rosuvastatin calcium tablets DRUG

In MAD part of study in patients with coronary atherosclerosis, Rosuvastatin calcium tablets will be taken orally by 10 mg daily up to 85 days

Also known as: Crestor®

Part II-Rosuvastatin calcium tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Chinese healthy male or female subjects between 18 and 55 years.
• 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.
• 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.
• 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.
• Willing and able to comply with the requirements of protocol.

You may not qualify if:

• Prior treatment with other investigational drug(s) within 3 months or 5 half-lives, whichever is longer, prior to the first dosing.
• 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.
• 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.
• Allergy to multiple kinds of drugs or presenting with history of allergic reactions to any components of the study drug.
• Presenting with history of myopathy/ myalgia, or susceptible to myopathy/ rhabdomyolysis.
• Presence of hypothyroidism.
• 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.
• Known inflammatory bowel disease, ulcers, gastrointestinal or rectal bleeding within 6 months prior to the first dosing.
• Presenting with history of pancreatic injury or pancreatitis within 6 months prior to the first dosing.
• Presence of symptoms of urinary obstruction or difficulty in voiding.
• Presenting and/ or relapse history (within the last 3 years) of autonomic dysfunction (e.g., recurrent episodes of fainting, palpitations, etc.).
• Evidence of major diseases that not recovered within 2 weeks prior to the first dosing, or major surgery is expected during the study.
• Presenting with history of impaired renal function defined by clinically significantly abnormal creatinine or BUN and/ or urea values, or abnormal urinary constituents (e.g., albuminuria).
• Presence of liver disease or liver injury, defined by abnormal liver function tests.
• Fasting triglyceride \> 3.4 mmol/L.

Sponsors & Collaborators

• Beijing Inno Medicine Co., Ltd.: lead

Study Sites (6)

Beijing Anzhen Hospital, Capital Medical University

Beijing, Beijing Municipality, 10000, China

Location

Peking University first hospital

Beijing, Beijing Municipality, 100034, China

Location

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Location

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Location

First Hospital of Jilin University

Changchun, Jilin, 130000, China

Location

Renji Hospital Shanghai Jiaotong Unv. school of Medicine

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Atherosclerosis

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive 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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2023
• First Posted: September 21, 2023
• Study Start: October 8, 2023
• Primary Completion: April 27, 2025
• Study Completion: April 27, 2025
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

CN (6)