A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Beijing Inno Medicine Co., Ltd.
Study ID
NCT07521007
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Atherosclerosis
  • Coronary Artery Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • YN001/Placebo 40mg — DRUG
    Dose 1 YN001/Placebo 40mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.
  • YN001/Placebo 20mg — DRUG
    YN001/Placebo 20mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.
  • YN001/Placebo 0mg — DRUG
    YN001/Placebo 0mg will be administrated on Day 1 of each week from Week 1 to Week 13, 13 times in total.

Study Details

This study is designed to evaluate the efficacy and safety of intravenously administered YN001 in patients diagnosed with coronary atherosclerosis, who are receiving background therapy for cardiovascular (CV) risk factors management.

Key Dates

First listed
Apr 9, 2026
Start date
Jul 30, 2026
Status verified
Jul 2026
Primary completion
Jul 31, 2027
Completion
Mar 31, 2029

Study Design

Enrollment
456 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose 1 YN001/Placebo 40mg
    Dose 1 YN001/Placobo 40mg will be administrated intravenously weekly
  • Experimental: Dose 2 YN001/Placebo 20mg
    Dose 2 YN001/Placebo 20mg will be administrated intravenously weekly
  • Placebo Comparator: Dose 3 YN001/Placebo 0mg
    Dose 3 YN001/Placebo 0mg will be administrated intravenously weekly

Primary Outcome Measure

Relative change from baseline in coronary NCPV at Week 13 [ Time Frame: Baseline to Week 13 ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Heart Center Research, LLCHuntsvilleAlabama35801
Herbert Haught, MD
[email protected]
256-519-8472
Clinical Trials ResearchLincolnCalifornia95648
Jeffrey Wayne, MD
[email protected]
913-626-9440
Stanford University School of MedicineStanfordCalifornia94305
Fahim Abbasi, MD
[email protected]
655-724-0954
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterTorranceCalifornia90502
Budoff Matthew, MD
[email protected]
310-222-4107
Excel Medical Clinical Trials dba Flourish Research - Boca RatonBoca RatonFlorida33434
Richard Goldman
[email protected]
561-756-8206
HCA Florida Heart InstitutePetersburgFlorida33709
Robert Sanchez, MD
[email protected]
727-490-2100
Southern Illinois University School of MedicineSpringfieldIllinois62781
Abdul Moiz Hafiz, MD
[email protected]
217-545-8000
Midwest Heart & Vascular SpecialistsOverland ParkKansas66209
Stepehen Bloom, MD
[email protected]
913-626-9440
Washington University School of MedicineSt LouisMissouri63110
Farhan Katchi, MD
[email protected]
314-454-7451
Wake Forest University Health SciencesWinston-SalemNorth Carolina27157
Michael Shapiro, MD
[email protected]
336-716-2718
The Carl & Edyth Lindner Center for Research & Education at The Christ HospitalCincinnatiOhio45219
Timothy Henry, MD
[email protected]
513-585-1777
Capital Area ResearchCamp HillPennsylvania17011
Venkatesh Nadar, MD
[email protected]
717-329-1592

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By research site
Heart Center Research, LLC· Huntsville, ALClinical Trials Research· Lincoln, CAStanford University School of Medicine· Stanford, CALundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center· Torrance, CAExcel Medical Clinical Trials dba Flourish Research - Boca Raton· Boca Raton, FLHCA Florida Heart Institute· Petersburg, FL

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