Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease
Purpose
The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
Condition
- Chronic Kidney Disease
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- Phase
- Phase 1
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Part A: OJR520 dose A1 |
Participants will receive OJR520 dose level A1. |
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|
Experimental Part A: OJR520 dose A2 |
Participants will receive OJR520 dose level A2. |
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|
Experimental Part A: OJR520 dose A3 |
Participants will receive OJR520 dose level A3. |
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Experimental Part A: OJR520 dose A4 |
Participants will receive OJR520 dose level A4. |
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Experimental Part A: OJR520 dose A5 |
Participants will receive OJR520 dose level A5. |
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Experimental Part A: OJR520 dose A6 |
Participants will receive OJR520 dose level A6. |
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|
Experimental Part B: OJR520 dose B1 |
Participants will receive OJR520 dose level B1. |
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Experimental Part B: OJR520 dose B2 |
Participants will receive OJR520 dose level B2. |
|
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Experimental Part B: OJR520 dose B3 |
Participants will receive OJR520 dose level B3. |
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|
Experimental Part B: OJR520 dose B4 |
Participants will receive OJR520 dose level B4. |
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Experimental Part C: OJR520 dose C1 |
Participants will receive OJR520 dose level C1. |
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Experimental Part C: OJR520 dose C2 |
Participants will receive OJR520 dose level C2. |
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|
Experimental Part C: OJR520 dose C3 |
Participants will receive OJR520 dose level C3. |
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|
Experimental Part C: OJR520 dose C4 |
Participants will receive OJR520 dose level C4. |
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Placebo Comparator Part A: Placebo |
Participants will receive the matching placebo. |
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Placebo Comparator Part B: Placebo |
Participants will receive the matching placebo. |
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|
Placebo Comparator Part C: Placebo |
Participants will receive the matching placebo. |
|
Recruiting Locations
Miami, Florida 33126
More Details
- Status
- Recruiting
- Sponsor
- Novartis Pharmaceuticals
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.