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

Novartis

Status and phase: Enrolling; Phase 1

Conditions: Chronic Kidney Disease

Treatments: Drug: OJR520; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07235059

COJR520A12101

Details and patient eligibility

About

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

Full 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.

Enrollment: 112 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Double Blind

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112 participants in 17 patient groups, including a placebo group

Part A: OJR520 dose A1

Experimental group

Description:

Participants will receive OJR520 dose level A1.

Treatment:

Drug: OJR520

Part A: OJR520 dose A2

Experimental group

Description:

Participants will receive OJR520 dose level A2.

Treatment:

Drug: OJR520

Part A: OJR520 dose A3

Experimental group

Description:

Participants will receive OJR520 dose level A3.

Treatment:

Drug: OJR520

Part A: OJR520 dose A4

Experimental group

Description:

Participants will receive OJR520 dose level A4.

Treatment:

Drug: OJR520

Part A: OJR520 dose A5

Experimental group

Description:

Participants will receive OJR520 dose level A5.

Treatment:

Drug: OJR520

Part A: OJR520 dose A6

Experimental group

Description:

Participants will receive OJR520 dose level A6.

Treatment:

Drug: OJR520

Part B: OJR520 dose B1

Experimental group

Description:

Participants will receive OJR520 dose level B1.

Treatment:

Drug: OJR520

Part B: OJR520 dose B2

Experimental group

Description:

Participants will receive OJR520 dose level B2.

Treatment:

Drug: OJR520

Part B: OJR520 dose B3

Experimental group

Description:

Participants will receive OJR520 dose level B3.

Treatment:

Drug: OJR520

Part B: OJR520 dose B4

Experimental group

Description:

Participants will receive OJR520 dose level B4.

Treatment:

Drug: OJR520

Part C: OJR520 dose C1

Experimental group

Description:

Participants will receive OJR520 dose level C1.

Treatment:

Drug: OJR520

Part C: OJR520 dose C2

Experimental group

Description:

Participants will receive OJR520 dose level C2.

Treatment:

Drug: OJR520

Part C: OJR520 dose C3

Experimental group

Description:

Participants will receive OJR520 dose level C3.

Treatment:

Drug: OJR520

Part C: OJR520 dose C4

Experimental group

Description:

Participants will receive OJR520 dose level C4.

Treatment:

Drug: OJR520

Part A: Placebo

Placebo Comparator group

Description:

Participants will receive the matching placebo.

Treatment:

Other: Placebo

Part B: Placebo

Placebo Comparator group

Description:

Participants will receive the matching placebo.

Treatment:

Other: Placebo

Part C: Placebo

Placebo Comparator group

Description:

Participants will receive the matching placebo.

Treatment:

Other: Placebo