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

NCT ID: NCT07235059

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-20

Study Completion Date

2027-07-19

Brief Summary

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

Detailed Description

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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

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Chronic Kidney Disease

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Part A: OJR520 dose A1

Participants will receive OJR520 dose level A1.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part A: OJR520 dose A2

Participants will receive OJR520 dose level A2.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part A: OJR520 dose A3

Participants will receive OJR520 dose level A3.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part A: OJR520 dose A4

Participants will receive OJR520 dose level A4.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part A: OJR520 dose A5

Participants will receive OJR520 dose level A5.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part A: OJR520 dose A6

Participants will receive OJR520 dose level A6.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part B: OJR520 dose B1

Participants will receive OJR520 dose level B1.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part B: OJR520 dose B2

Participants will receive OJR520 dose level B2.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part B: OJR520 dose B3

Participants will receive OJR520 dose level B3.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part B: OJR520 dose B4

Participants will receive OJR520 dose level B4.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part C: OJR520 dose C1

Participants will receive OJR520 dose level C1.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part C: OJR520 dose C2

Participants will receive OJR520 dose level C2.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part C: OJR520 dose C3

Participants will receive OJR520 dose level C3.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part C: OJR520 dose C4

Participants will receive OJR520 dose level C4.

Group Type EXPERIMENTAL

OJR520

Intervention Type DRUG

Participants will receive OJR520 in different dose levels.

Part A: Placebo

Participants will receive the matching placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants will receive OJR520 matching placebo.

Part B: Placebo

Participants will receive the matching placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants will receive OJR520 matching placebo.

Part C: Placebo

Participants will receive the matching placebo.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Participants will receive OJR520 matching placebo.

Interventions

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OJR520

Participants will receive OJR520 in different dose levels.

Intervention Type DRUG

Placebo

Participants will receive OJR520 matching placebo.

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Quotient Sciences Sea View

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: 1-888-669-6682

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Facility Contacts

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Arline Mata

Role: primary

Other Identifiers

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2025-520978-18

Identifier Type: OTHER

Identifier Source: secondary_id

COJR520A12101

Identifier Type: -

Identifier Source: org_study_id