NCT07235059

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Chronic Kidney Disease

Interventions

Type	Name	Description
DRUG	OJR520	Participants will receive OJR520 in different dose levels.
OTHER	Placebo	Participants will receive OJR520 matching placebo.

Timeline

• Start date: 2025-11-20
• Primary completion: 2027-07-19
• Completion: 2027-07-19
• First posted: 2025-11-19
• Last updated: 2026-03-23

Locations

2 sites across 2 countries: United States, Germany

Regulatory

• FDA-regulated drug study