Actively Recruiting
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
Led by Novartis Pharmaceuticals · Updated on 2026-05-05
112
Participants Needed
2
Research Sites
113 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
CONDITIONS
Official Title
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able to provide written informed consent before any assessment
- Healthy males and females in good health by medical history, physical exam, vital signs, ECG, and labs (Part A)
- Males and females aged 18 to 65 years (Parts B & C)
You will not qualify if you...
- Women of childbearing potential
- Sexually active males unwilling to use contraception
- Clinically significant abnormal blood pressure (SBP <90 or >140 mmHg; DBP <55 or >95 mmHg) (Part A)
- Abnormal resting heart rate (<45 bpm or >90 bpm) (Part A)
- History or active significant illness including cancer (except non-melanoma skin cancer), severe heart failure, heart rhythm abnormalities, autoimmune CKD, kidney transplant, dialysis, or other serious conditions (Parts B & C)
- Clinically significant aortic stenosis or mitral insufficiency by echocardiography (Parts B & C)
- History of myocardial infarction, stroke, coronary artery bypass graft, percutaneous coronary intervention, or transient ischemic attack (Parts B & C)
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Trial Site Locations
Total: 2 locations
1
Quotient Sciences Sea View
Miami, Florida, United States, 33126
Actively Recruiting
2
Novartis Investigative Site
Berlin, Germany, 10117
Actively Recruiting
Research Team
N
Novartis Pharmaceuticals
CONTACT
N
Novartis Pharmaceuticals
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
17
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