Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease

Recruiting now · Phase 1 · Has a placebo group

Conditions studied: Chronic Kidney Disease

In brief

The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.

Key facts

Study ID

NCT07235059

Run by

Novartis Pharmaceuticals

People needed

112

Starts

2025-11-20

Expected to finish

2028-01-21

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to provide written informed consent before any assessment is performed.
• Part A (HV):
• Healthy male and female participants in good health as determined by past medical history, physical examination, vital signs, 12-lead ECG, and laboratory tests at screening and baseline within the normal range.
• Parts B \& C (CKD)
• Male and female participants 18 to 65 years of age.

You may not qualify if…

• Women of childbearing potential.
• Sexually active males unwilling to use contraception.
• Part A (HV):
• Clinically significant abnormal blood pressure, defined as SBP <90 mmHg or >140 mmHg or DBP <55 mmHg or >95 mmHg.
• Abnormal resting HR, defined as <45 bpm or >90 bpm.
• Part B \& C (CKD)
• History of, or currently active, significant illness or medical disorders including, but not limited to, cancer (except for non-melanoma skin cancer), heart failure NYHA III-IV, heart rhythm abnormalities (e.g., atrial fibrillation, sick sinus syndrome, permanent pacemaker), CKD due to autoimmune disease, kidney transplant, dialysis or any other disease the investigator believes may preclude the participant from participating in the this study.
• Clinically significant aortic stenosis or mitral insufficiency as identified via echocardiography.
• History of myocardial infarction (MI), stroke, coronary artery bypass graft (CABG), percutaneous coronary intervention (PCI), or transient ischemic attack (TIA).
• Other protocol defined inclusion/exclusion criteria may apply.

Where it is running

• Quotient Sciences Sea View — Miami, Florida, United States (enrolling)
• Novartis Investigative Site — Berlin, Germany (enrolling)

Full record on ClinicalTrials.gov

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