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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Kidney Disease
• Intervention / Treatment: Drug: OJR520; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 112
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Novartis Pharmaceuticals; Phone Number: 1-888-669-6682; Email: novartis.email@novartis.com
• Study Contact Backup: Name: Novartis Pharmaceuticals; Phone Number: +41613241111

Study Locations

• Germany
  • Berlin, Germany, 10117
    • Recruiting
    • Novartis Investigative Site
• United States
  • Florida
    • Miami, Florida, United States, 33126
      • Recruiting
      • Quotient Sciences Sea View
      • Principal Investigator: Juliet Vento
      • Contact: Arline Mata; Phone Number: 305-644-9903; Email: arline.mata@quotientsciences.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Double

Number of Arms

17

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part A: OJR520 dose A1; Participants will receive OJR520 dose level A1.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part A: OJR520 dose A2; Participants will receive OJR520 dose level A2.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part A: OJR520 dose A3; Participants will receive OJR520 dose level A3.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part A: OJR520 dose A4; Participants will receive OJR520 dose level A4.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part A: OJR520 dose A5; Participants will receive OJR520 dose level A5.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part A: OJR520 dose A6; Participants will receive OJR520 dose level A6.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part B: OJR520 dose B1; Participants will receive OJR520 dose level B1.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part B: OJR520 dose B2; Participants will receive OJR520 dose level B2.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part B: OJR520 dose B3; Participants will receive OJR520 dose level B3.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part B: OJR520 dose B4; Participants will receive OJR520 dose level B4.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part C: OJR520 dose C1; Participants will receive OJR520 dose level C1.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part C: OJR520 dose C2; Participants will receive OJR520 dose level C2.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part C: OJR520 dose C3; Participants will receive OJR520 dose level C3.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Experimental: Part C: OJR520 dose C4; Participants will receive OJR520 dose level C4.	Drug: OJR520; Participants will receive OJR520 in different dose levels.
Placebo Comparator: Part A: Placebo; Participants will receive the matching placebo.	Other: Placebo; Participants will receive OJR520 matching placebo.
Placebo Comparator: Part B: Placebo; Participants will receive the matching placebo.	Other: Placebo; Participants will receive OJR520 matching placebo.
Placebo Comparator: Part C: Placebo; Participants will receive the matching placebo.	Other: Placebo; Participants will receive OJR520 matching placebo.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs)	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.	From Day 1 (Part A) until Day 71 (Part C)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Observed Blood Concentrations (Cmax)	Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1).	From pre-dose Day 1 (Part A) until Day 71 (Part C)
Time to reach maximum plasma concentration (Tmax)	Tmax is the time to reach maximum (peak) drug concentration after single-dose administration (time).	From pre-dose Day 1 (Part A) until Day 71 (Part C)
Area under plasma concentration-time curve (AUClast)	AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast).	From pre-dose Day 1 (Part A) until Day 71 (Part C)
Area under the plasma concentration-time curve (AUC[0-inf])	The AUC[0-inf] from time zero extrapolated to infinity (mass x time x volume-1).	From pre-dose Day 1 (Part A) until Day 71 (Part C)
Terminal elimination half-life (T1/2)	T1/2 is the elimination half-life associated with the terminal slope.	From pre-dose Day 1 (Part A) until Day 71 (Part C)
Apparent plasma clearance (CL/F)	CL/F is the apparent total body clearance of drug from plasma following extravascular administration.	From pre-dose Day 1 (Part A) until Day 71 (Part C)
Apparent volume of distribution during terminal elimination phase (Vz/F)	Vz/F is the apparent volume of distribution during terminal elimination phase following extravascular administration.	From pre-dose Day 1 (Part A) until Day 71 (Part C)
Drug accumulation ratio (Racc)	The ratio of accumulation of drug between the first and last dose, only for MAD part of the study.	Part C: From pre-dose Day 1 until Day 71
Area under plasma concentration-time curve (AUCtau)	The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1) only for MAD part of the study.	Part C: From pre-dose Day 1 until Day 71

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2025
• Primary Completion (Estimated): January 21, 2028
• Study Completion (Estimated): January 21, 2028

Study Registration Dates

• First Submitted: November 14, 2025
• First Submitted That Met QC Criteria: November 14, 2025
• First Posted (Actual): November 19, 2025

Study Record Updates

• Last Update Posted (Actual): May 5, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: PK; chronic kidney disease; healthy volunteers; PD; safety and tolerability; first in human; OJR520
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic
• Other Study ID Numbers: COJR520A12101; 2025-520978-18 (Other Identifier: EU Trial (CTIS) number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No