RecruitingPhase 1NCT07235059

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

Sponsor

Novartis Pharmaceuticals

Enrollment

112 participants

Start Date

Nov 20, 2025

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease

Summary

The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety and how a new drug called OJR520 moves through the body in both healthy people and people with chronic kidney disease (CKD), where the kidneys do not filter blood as well as they should. **You may be eligible if...** - You are a healthy adult in generally good health (for the healthy volunteer group), OR - You are between 18 and 65 years old with chronic kidney disease (for the CKD groups) **You may NOT be eligible if...** - You are a woman who could become pregnant - You are a sexually active male unwilling to use contraception - You have significant abnormal blood pressure or heart rate (healthy volunteers) - You have other active serious illnesses (CKD participants) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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