NCT07235059 Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
| NCT ID | NCT07235059 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Novartis Pharmaceuticals |
| Condition | Chronic Kidney Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 112 participants |
| Start Date | 2025-11-20 |
| Primary Completion | 2028-01-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 112 participants in total. It began in 2025-11-20 with a primary completion date of 2028-01-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
Eligibility Criteria
Inclusion Criteria: 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 Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07235059 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Chronic Kidney Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07235059 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07235059 currently recruiting?
Yes, NCT07235059 is actively recruiting participants. Contact the research team at novartis.email@novartis.com for enrollment information.
Where is the NCT07235059 trial being conducted?
This trial is being conducted at Miami, United States, Berlin, Germany.
Who is sponsoring the NCT07235059 clinical trial?
NCT07235059 is sponsored by Novartis Pharmaceuticals. The trial plans to enroll 112 participants.
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