Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
OJR520 · 1 trial · 1 indication
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.
| Arm | Type | Description |
|---|---|---|
| Part A: OJR520 dose A1 | EXPERIMENTAL | Participants will receive OJR520 dose level A1. |
| Part A: OJR520 dose A2 | EXPERIMENTAL | Participants will receive OJR520 dose level A2. |
| Part A: OJR520 dose A3 | EXPERIMENTAL | Participants will receive OJR520 dose level A3. |
| Part A: OJR520 dose A4 | EXPERIMENTAL | Participants will receive OJR520 dose level A4. |
| Part A: OJR520 dose A5 | EXPERIMENTAL | Participants will receive OJR520 dose level A5. |
| Part A: OJR520 dose A6 | EXPERIMENTAL | Participants will receive OJR520 dose level A6. |
| Part B: OJR520 dose B1 | EXPERIMENTAL | Participants will receive OJR520 dose level B1. |
| Part B: OJR520 dose B2 | EXPERIMENTAL | Participants will receive OJR520 dose level B2. |
| Part B: OJR520 dose B3 | EXPERIMENTAL | Participants will receive OJR520 dose level B3. |
| Part B: OJR520 dose B4 | EXPERIMENTAL | Participants will receive OJR520 dose level B4. |
| Part C: OJR520 dose C1 | EXPERIMENTAL | Participants will receive OJR520 dose level C1. |
| Part C: OJR520 dose C2 | EXPERIMENTAL | Participants will receive OJR520 dose level C2. |
| Part C: OJR520 dose C3 | EXPERIMENTAL | Participants will receive OJR520 dose level C3. |
| Part C: OJR520 dose C4 | EXPERIMENTAL | Participants will receive OJR520 dose level C4. |
| Part A: Placebo | PLACEBO_COMPARATOR | Participants will receive the matching placebo. |
| Part B: Placebo | PLACEBO_COMPARATOR | Participants will receive the matching placebo. |
| Part C: Placebo | PLACEBO_COMPARATOR | Participants will receive the matching placebo. |
| Name | Type | Description |
|---|---|---|
| OJR520 | DRUG | Participants will receive OJR520 in different dose levels. |
| Placebo | OTHER | Participants will receive OJR520 matching placebo. |
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...
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OJR520 is an investigational small molecule being developed for Chronic Kidney Disease. It is currently in Phase 1 clinical development, meaning it has not been approved by regulatory authorities. The drug is being studied to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and participants with Chronic Kidney Disease.
OJR520 is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting a Phase 1 clinical trial to assess the drug's safety and other characteristics in patients with Chronic Kidney Disease.
OJR520 is in Phase 1 of clinical development. It is an investigational drug, meaning it has not yet been approved for use in patients. The ongoing Phase 1 trial is recruiting participants to study the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy volunteers and individuals with Chronic Kidney Disease.
OJR520 is being studied in one Phase 1 clinical trial with the identifier NCT07235059. This randomized, double-blind, placebo-controlled trial is recruiting 112 participants in the United States and Germany. The study evaluates the safety, tolerability, pharmacokinetics, and pharmacodynamics of OJR520 in healthy volunteers and participants with Chronic Kidney Disease.
OJR520 is not FDA approved. It is an investigational drug currently in Phase 1 clinical trials. The drug is being studied for Chronic Kidney Disease, but it has not yet completed the clinical development process required for regulatory approval. The ongoing trial is focused on assessing safety and tolerability in humans.