Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: OJR520, Placebo.
- Who it may be relevant to
- Registry conditions: Chronic Kidney Disease. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
Detailed description
This is a three-part randomized, participant- and investigator blinded, placebo-controlled, multi-center, sequential study: single ascending dose (SAD) in healthy volunteers (HV), SAD in participants with chronic kidney disease (CKD) or diabetic chronic kidney disease (DKD) and multiple ascending dose (MAD) in participants with CKD or DKD.
Interventions
- Drug OJR520
Participants will receive OJR520 in different dose levels. - Other Placebo
Participants will receive OJR520 matching placebo.
Primary outcome measures
- Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) [Time frame: From Day 1 (Part A) until Day 71 (Part C)]
Secondary outcome measures (9)
- Maximum Observed Blood Concentrations (Cmax) [Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)]
- Time to reach maximum plasma concentration (Tmax) [Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)]
- Area under plasma concentration-time curve (AUClast) [Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)]
- Area under the plasma concentration-time curve (AUC[0-inf]) [Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)]
- Terminal elimination half-life (T1/2) [Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)]
- Apparent plasma clearance (CL/F) [Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)]
- Apparent volume of distribution during terminal elimination phase (Vz/F) [Time frame: From pre-dose Day 1 (Part A) until Day 71 (Part C)]
- Drug accumulation ratio (Racc) [Time frame: Part C: From pre-dose Day 1 until Day 71]
- Area under plasma concentration-time curve (AUCtau) [Time frame: Part C: From pre-dose Day 1 until Day 71]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Quotient Sciences Sea View — Miami
Germany · 1 center
- Novartis Investigative Site — Berlin
Identifiers
NCT: NCT07235059 · COJR520A12101 · 2025-520978-18