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Study of OJR520 for Chronic Kidney Disease

This study is testing a new drug called OJR520 to see if it is safe and well-tolerated in healthy volunteers and people with chronic kidney disease (CKD). Researchers also want to understand how the body processes OJR520 (pharmacokinetics) and how it affects the body (pharmacodynamics). You might receive OJR520 or a placebo (an inactive substance that looks like the drug). The main goal is to track any side effects. This study is open to men and women aged 18 to 65 years. The study aims to enroll 112 participants, but its current recruitment status is unclear.

Study design
This is a randomized, placebo-controlled study where neither you nor the study staff will know if you are receiving OJR520 or the placebo. It has three parts, including testing different doses in healthy volunteers and people with CKD.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored from the first day of the study until Day 71 for some participants.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07235059

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Novartis Pharmaceuticals
~112 participants
Updated 2026-08-19 on ClinicalTrials.gov
What's tested:OJR520Placebo

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)
Measured over From Day 1 (Part A) until Day 71 (Part C)

Conditions

Chronic Kidney Disease

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NCT07235059

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Quotient Sciences Sea View

    Miami, Floridastudy coordinator listed

    Recruiting

  • Novartis Investigative Site

    Berlin, Germanyno site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Novartis Pharmaceuticals
[email protected]
1-888-669-6682
Email the study team

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Eligibility criteria

Exclusion

Women of childbearing potential.
Sexually active males unwilling to use contraception.
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.
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).

What this trial measures

  • Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)From Day 1 (Part A) until Day 71 (Part C)

    Incidence and severity of AEs and SAEs by treatment group, including changes in vital signs, electrocardiograms (ECGs) and laboratory results qualifying and reported as AEs.