First study of OJR520 in healthy volunteers and people with chronic kidney disease
Tests OJR520 for safety in healthy adults and adults with chronic kidney disease.
Plain-language title generated from the registry record
Registry title: Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
Key facts
- Where
- Berlin, GermanySee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07235059, who can take part
Where in Germany
- BerlinBerlin, GermanyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT07235059
- Record updated
- 10 November 2026
- Original description
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.Read full original descriptionShow less
A Participant- and Investigator--Blinded, Placebo- Controlled, Randomized, Multipart, Single and Multiple Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
Inclusion: 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.
Exclusion: 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; 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).