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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-520978-18 | Other Identifier | EU Trial (CTIS) number |
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The purpose of this first-in-human (FIH) study is to evaluate safety, tolerability, pharmacokinetic (PK) of OJR520.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A: OJR520 dose A1 | Experimental | Participants will receive OJR520 dose level A1. |
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| Part A: OJR520 dose A2 | Experimental | Participants will receive OJR520 dose level A2. |
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| Part A: OJR520 dose A3 | Experimental | Participants will receive OJR520 dose level A3. |
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| Part A: OJR520 dose A4 | Experimental | Participants will receive OJR520 dose level A4. |
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| Part A: OJR520 dose A5 | Experimental | Participants will receive OJR520 dose level A5. |
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| Part A: OJR520 dose A6 | Experimental | Participants will receive OJR520 dose level A6. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OJR520 | Drug | Participants will receive OJR520 in different dose levels. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Observed Blood Concentrations (Cmax) | Cmax is the maximum (peak) observed plasma, blood, serum, or other body fluid drug concentration after single dose administration (mass x volume-1). | From pre-dose Day 1 (Part A) until Day 71 (Part C) |
| Time to reach maximum plasma concentration (Tmax) |
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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:
Part A (HV):
Part B & C (CKD)
Other protocol defined inclusion/exclusion criteria may apply.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | 1-888-669-6682 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact | +41613241111 |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences Sea View | Recruiting | Miami | Florida | 33126 | United States |
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| Part B: OJR520 dose B1 | Experimental | Participants will receive OJR520 dose level B1. |
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| Part B: OJR520 dose B2 | Experimental | Participants will receive OJR520 dose level B2. |
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| Part B: OJR520 dose B3 | Experimental | Participants will receive OJR520 dose level B3. |
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| Part B: OJR520 dose B4 | Experimental | Participants will receive OJR520 dose level B4. |
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| Part C: OJR520 dose C1 | Experimental | Participants will receive OJR520 dose level C1. |
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| Part C: OJR520 dose C2 | Experimental | Participants will receive OJR520 dose level C2. |
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| Part C: OJR520 dose C3 | Experimental | Participants will receive OJR520 dose level C3. |
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| Part C: OJR520 dose C4 | Experimental | Participants will receive OJR520 dose level C4. |
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| Part A: Placebo | Placebo Comparator | Participants will receive the matching placebo. |
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| Part B: Placebo | Placebo Comparator | Participants will receive the matching placebo. |
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| Part C: Placebo | Placebo Comparator | Participants will receive the matching placebo. |
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| Placebo | Other | Participants will receive OJR520 matching placebo. |
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Tmax is the time to reach maximum (peak) drug concentration after single-dose administration (time). |
| From pre-dose Day 1 (Part A) until Day 71 (Part C) |
| Area under plasma concentration-time curve (AUClast) | AUClast is the area under the plasma concentration-time curve from time zero to the time of last quantifiable concentration (tlast). | From pre-dose Day 1 (Part A) until Day 71 (Part C) |
| Area under the plasma concentration-time curve (AUC[0-inf]) | The AUC[0-inf] from time zero extrapolated to infinity (mass x time x volume-1). | From pre-dose Day 1 (Part A) until Day 71 (Part C) |
| Terminal elimination half-life (T1/2) | T1/2 is the elimination half-life associated with the terminal slope. | From pre-dose Day 1 (Part A) until Day 71 (Part C) |
| Apparent plasma clearance (CL/F) | CL/F is the apparent total body clearance of drug from plasma following extravascular administration. | From pre-dose Day 1 (Part A) until Day 71 (Part C) |
| Apparent volume of distribution during terminal elimination phase (Vz/F) | Vz/F is the apparent volume of distribution during terminal elimination phase following extravascular administration. | From pre-dose Day 1 (Part A) until Day 71 (Part C) |
| Drug accumulation ratio (Racc) | The ratio of accumulation of drug between the first and last dose, only for MAD part of the study. | Part C: From pre-dose Day 1 until Day 71 |
| Area under plasma concentration-time curve (AUCtau) | The AUC calculated to the end of a dosing interval (tau) (amount x time x volume-1) only for MAD part of the study. | Part C: From pre-dose Day 1 until Day 71 |
| Novartis Investigative Site | Recruiting | Berlin | 10117 | Germany |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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