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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07024823 | A Study to Investigate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AZD4248 in Healthy Participants and Participants With Chronic Kidney Disease and Type 2 Diabetes and to Assess Home Measurements of Creatinine in a Non Interventional Cohort | PHASE1 | RECRUITING | 124 | — | — | Jun 9, 2025 | Jun 18, 2026 | Apr 20, 2026 | 5 | United States |
To assess the safety and tolerability of AZD4248 following single oral ascending doses or single IV administration to healthy participants and multiple oral ascending doses to healthy participants and participants with CKD and T2D (DKD).
To assess intra- and inter-participant variability of twice weekly home-based serum creatinine measurements.
| Arm | Type | Description |
|---|---|---|
| Part A1 SAD | EXPERIMENTAL | Participants will receive single ascending oral dose of AZD4248 or placebo. |
| Part A2 SAD Chinese Cohort | EXPERIMENTAL | Participants will receive single oral dose of AZD4248 or placebo. |
| Part A3 SAD IV Cohort | EXPERIMENTAL | Participants will receive single IV infusion of AZD4248 or placebo. |
| Part B1 MAD | EXPERIMENTAL | Participants will receive multiple ascending oral doses of AZD4248 or placebo. |
| Part B2 MAD Japanese | EXPERIMENTAL | Participants will receive multiple ascending oral doses of AZD4248 or placebo. |
| Part C Multiple Dosing DKD | EXPERIMENTAL | Participants will receive multiple oral doses of AZD4248 or placebo. |
| Part D Observational Cohort | NO_INTERVENTION | Participants will participate in home-based creatinine self-measurement. |
| Name | Type | Description |
|---|---|---|
| AZD4248 | DRUG | AZD4248 will be administered orally. |
| Placebo | DRUG | Placebo will be administered orally. |
Key Inclusion Criteria: \- Healthy participants with suitable veins for cannulation or repeated venipuncture. Parts A and B: * Have a body mass index (BMI) between 18 and 30 kilograms per millimeter (kg/m2), inclusive. * For Chinese participants (Part A2): participants are to be Chinese, defined ...