A Phase 2b Clinical Trial of YN001 in Adults With Coronary Atherosclerosis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorBeijing Inno Medicine Co., Ltd.
About this trial
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.
Eligibility criteria
Qualifiers
Fully understands the purposes, features, and methods of the study and the possible adverse reactions, and is voluntarily willing to participate in the study, and signs the informed consent form (ICF) before performing any study-specific assessment.
Male or female participants between 18 and 80 years (inclusive, at the time of signing the ICF).
A history of Type 2 diabetes requiring treatment with medication,
Aged > 55 years (women) or > 50 years (men),
Disqualifiers
Prior treatment with other investigational drug(s) within 30 days or 5 half-lives, whichever is longer, prior to randomization.
Previously received YN001.
Any type of vaccination within 4 weeks prior to randomization, or any planned vaccination during the study treatment period
Contraindication for CCTA
Trial design
Treatments tested in this trial
- YN001/Placebo 40mg
- YN001/Placebo 20mg
- YN001/Placebo 0mg
Treatment groups
456 Participants
are divided into 3 treatment groupsSponsors and collaborators
Beijing Inno Medicine Co., Ltd.
Lead sponsor
The TIMI Study Group
Collaborator
Source ClinicalTrials.gov