Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease

NCT07235059 | Recruiting Phase 1 FDA Drug

• 2 other identifiers: COJR520A121012025-520978-18
• Study Type: interventional
• Target: 112
• Locations: 2 countries
• Sites: 2

Brief Summary

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

Conditions

Chronic Kidney Disease

Keywords

OJR520; safety and tolerability; PK; PD; healthy volunteers; first in human; chronic kidney disease

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Maximum Observed Blood Concentrations (Cmax)

  From pre-dose Day 1 (Part A) until Day 71 (Part C)

• Time to reach maximum plasma concentration (Tmax)

  From pre-dose Day 1 (Part A) until Day 71 (Part C)

• Area under plasma concentration-time curve (AUClast)

  From pre-dose Day 1 (Part A) until Day 71 (Part C)

• Area under the plasma concentration-time curve (AUC[0-inf])

  From pre-dose Day 1 (Part A) until Day 71 (Part C)

• Terminal elimination half-life (T1/2)

  From pre-dose Day 1 (Part A) until Day 71 (Part C)

Study Arms (17)

Part A: OJR520 dose A1

EXPERIMENTAL

Participants will receive OJR520 dose level A1.

Drug: OJR520

Part A: OJR520 dose A2

EXPERIMENTAL

Participants will receive OJR520 dose level A2.

Drug: OJR520

Part A: OJR520 dose A3

EXPERIMENTAL

Participants will receive OJR520 dose level A3.

Drug: OJR520

Part A: OJR520 dose A4

EXPERIMENTAL

Participants will receive OJR520 dose level A4.

Drug: OJR520

Part A: OJR520 dose A5

EXPERIMENTAL

Participants will receive OJR520 dose level A5.

Drug: OJR520

Part A: OJR520 dose A6

EXPERIMENTAL

Participants will receive OJR520 dose level A6.

Drug: OJR520

Part B: OJR520 dose B1

EXPERIMENTAL

Participants will receive OJR520 dose level B1.

Drug: OJR520

Part B: OJR520 dose B2

EXPERIMENTAL

Participants will receive OJR520 dose level B2.

Drug: OJR520

Part B: OJR520 dose B3

EXPERIMENTAL

Participants will receive OJR520 dose level B3.

Drug: OJR520

Part B: OJR520 dose B4

EXPERIMENTAL

Participants will receive OJR520 dose level B4.

Drug: OJR520

Part C: OJR520 dose C1

EXPERIMENTAL

Participants will receive OJR520 dose level C1.

Drug: OJR520

Part C: OJR520 dose C2

EXPERIMENTAL

Participants will receive OJR520 dose level C2.

Drug: OJR520

Part C: OJR520 dose C3

EXPERIMENTAL

Participants will receive OJR520 dose level C3.

Drug: OJR520

Part C: OJR520 dose C4

EXPERIMENTAL

Participants will receive OJR520 dose level C4.

Drug: OJR520

Part A: Placebo

PLACEBO COMPARATOR

Participants will receive the matching placebo.

Other: Placebo

Part B: Placebo

PLACEBO COMPARATOR

Participants will receive the matching placebo.

Other: Placebo

Part C: Placebo

PLACEBO COMPARATOR

Participants will receive the matching placebo.

Other: Placebo

Interventions

OJR520 DRUG

Participants will receive OJR520 in different dose levels.

Part A: OJR520 dose A1; Part A: OJR520 dose A2; Part A: OJR520 dose A3; Part A: OJR520 dose A4; Part A: OJR520 dose A5; Part A: OJR520 dose A6; Part B: OJR520 dose B1; Part B: OJR520 dose B2; Part B: OJR520 dose B3; Part B: OJR520 dose B4; Part C: OJR520 dose C1; Part C: OJR520 dose C2; Part C: OJR520 dose C3; Part C: OJR520 dose C4

Placebo OTHER

Participants will receive OJR520 matching placebo.

Part A: Placebo; Part B: Placebo; Part C: Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (2)

Quotient Sciences Sea View

Miami, Florida, 33126, United States

RECRUITING

Novartis Investigative Site

Berlin, 10117, Germany

RECRUITING

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: November 20, 2025
• Primary Completion (Estimated): January 21, 2028
• Study Completion (Estimated): January 21, 2028
• Last Updated: May 5, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); DE (1)