Clinical Trials in the USA / NCT07235059
Recruiting
Phase 1
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
NCT07235059 · tracked via the Priya Life Science USA tracker
Condition(s) studied
Chronic Kidney Disease
Investigational drug(s) / intervention(s)
OJR520Placebo
OJR520: Participants will receive OJR520 in different dose levels.
Placebo: Participants will receive OJR520 matching placebo.
Study summary
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
Eligibility
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.
Primary outcome measure(s)
- 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.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| Quotient Sciences Sea View | Miami | Florida | Recruiting |
| Novartis Investigative Site | Berlin | Germany | Recruiting |
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Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07235059 on ClinicalTrials.gov ↗ ← All trials in the USA