Recruiting
Phase 1

OJR520

Sponsor:

Novartis Pharmaceuticals

Code:

NCT07235059

Conditions

Chronic Kidney Disease

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

OJR520

Placebo

Study Details

Brief summary:

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

Conditions

Chronic Kidney Disease

Study ID

NCT07235059

Start date

Nov 20, 2025

Status verified date

Aug, 2026

Completion date

Jan 21, 2028

Anticipated

Primary completion date

Jan 21, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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 Design

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A: OJR520 dose A1

Participants will receive OJR520 dose level A1.

experimental: Part A: OJR520 dose A2

Participants will receive OJR520 dose level A2.

experimental: Part A: OJR520 dose A3

Participants will receive OJR520 dose level A3.

experimental: Part A: OJR520 dose A4

Participants will receive OJR520 dose level A4.

experimental: Part A: OJR520 dose A5

Participants will receive OJR520 dose level A5.

experimental: Part A: OJR520 dose A6

Participants will receive OJR520 dose level A6.

experimental: Part B: OJR520 dose B1

Participants will receive OJR520 dose level B1.

experimental: Part B: OJR520 dose B2

Participants will receive OJR520 dose level B2.

experimental: Part B: OJR520 dose B3

Participants will receive OJR520 dose level B3.

experimental: Part B: OJR520 dose B4

Participants will receive OJR520 dose level B4.

experimental: Part C: OJR520 dose C1

Participants will receive OJR520 dose level C1.

experimental: Part C: OJR520 dose C2

Participants will receive OJR520 dose level C2.

experimental: Part C: OJR520 dose C3

Participants will receive OJR520 dose level C3.

experimental: Part C: OJR520 dose C4

Participants will receive OJR520 dose level C4.

placebo comparator: Part A: Placebo

Participants will receive the matching placebo.

placebo comparator: Part B: Placebo

Participants will receive the matching placebo.

placebo comparator: Part C: Placebo

Participants will receive the matching placebo.

Interventions

OJR520

Participants will receive OJR520 in different dose levels.

Placebo

Participants will receive OJR520 matching placebo.

Primary outcome measure

  • Number of participants with Adverse events (AEs) and Serious Adverse events (SAEs) [ Time Frame: From Day 1 (Part A) until Day 71 (Part C) ]

Central Contacts and Locations

Central contacts

Novartis Pharmaceuticals

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

Novartis Pharmaceuticals

+41613241111

Locations

Quotient Sciences Sea View

Recruiting

Miami, Florida, United States, 33126

Contacts

Daniela Perez

+1 305 644 9903daniela.perez@quotientsciences.com

Principal Investigator:

Juliet Vento

More Information

Sponsor

Novartis Pharmaceuticals

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Novartis Pharmaceuticals on 2026-08-19.