NCT07235059RecruitingPhase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
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
Source: ClinicalTrials.gov · Last updated 19 Aug 2026
Brief summary (registry, in English)
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 112 (estimated)
- First submitted
- 14 Nov 2025
- Start date
- 20 Nov 2025
- Primary completion date
- 21 Jan 2028
- Lead sponsor
- Novartis Pharmaceuticals
- Diseases
- Chronic kidney disease
- NCT number
- NCT07235059
- EudraCT number
- 2025-520978-18
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 112
- From 20 Nov 2025 to the primary completion date, 21 Jan 2028
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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.
Other
- 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)
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Berlin | Germany | Recruiting |
| Quotient Sciences Sea View Coordinator of this site? Confirm its status | Miami | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.