Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07235059 | Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of OJR520 in Healthy Volunteers and Participants With Chronic Kidney Disease | PHASE1 | RECRUITING | 112 | — | — | Nov 20, 2025 | Jan 21, 2028 | May 5, 2026 | 2 | United States, Germany |
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...