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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05793450 | Pharmacokinetics of IBI362 in Subjects With and Without Renal Impairment | PHASE1 | COMPLETED | 20 | — | — | May 5, 2023 | Nov 17, 2023 | Feb 20, 2024 | 1 | China |
| Arm | Type | Description |
|---|---|---|
| IBI362 - Mild and Moderate Renal Impairment | EXPERIMENTAL | Group 2 - IBI362 administered SC to participants with mild and moderate renal impairment. |
| IBI362 - Healthy | EXPERIMENTAL | Group 1 - IBI362 administered subcutaneously (SC) to healthy participants with normal renal function. |
| IBI362 - Severe Renal Impairment | EXPERIMENTAL | Group 3 - IBI362 administered SC to participants with severe renal impairment. |
| Name | Type | Description |
|---|---|---|
| IBI362 | DRUG | 2.0mg, SC, single dose |
Inclusion Criteria: * All Participants: o The weight of male subjects is not less than 50 kg, and the body weight of female subjects is not less than 45 kg, and the body mass index (BMI) is within the range of 20\~30 kilograms per meter squared (kg/m²), inclusive, at screening * Healthy Particip...