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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06995820 | A Study to Investigate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of AZD1613 in Healthy Participants. | PHASE1 | RECRUITING | 136 | — | — | Jun 6, 2025 | Sep 23, 2026 | May 15, 2026 | 1 | United States |
To assess the safety and tolerability of AZD1613 following SC and/or IV administration of single and multiple ascending doses.
| Arm | Type | Description |
|---|---|---|
| Part A1 (SAD): AZD1613 (Dose 1) SC | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 1) or matching placebo to AZD1613 as SC injection on Day 1. |
| Part A1 (SAD): AZD1613 (Dose 2) SC | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 2) or matching placebo to AZD1613 as SC injection on Day 1. |
| Part A1 (SAD): AZD1613 (Dose 3) SC | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 3) or matching placebo to AZD1613 as SC injection on Day 1. |
| Part A1 (SAD): AZD1613 (Dose 4) SC | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 4) or matching placebo to AZD1613 as SC injection on Day 1. |
| Part A1 (SAD): AZD1613 (Dose 5) IV | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 5) or matching placebo to AZD1613 as an IV infusion on Day 1. |
| Part A1 (SAD): AZD1613 (Dose 6) IV | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 6) or matching placebo to AZD1613 as an IV infusion on Day 1. |
| Part A1 (SAD): AZD1613 (Dose 7) IV | EXPERIMENTAL | Participants will receive a single dose of AZD1613 (Dose 7) or matching placebo to AZD1613 as an IV infusion on Day 1. |
| Part A2 (SAD): AZD1613 (Dose 8) IV (Chinese) | EXPERIMENTAL | Chinese participants will receive a single dose of AZD1613 (Dose 8) or matching placebo to AZD1613 as an IV infusion on Day 1. |
| Part A3 (SAD): AZD1613 (Dose 9) SC or IV (Japanese) | EXPERIMENTAL | Japanese participants will receive a single dose of AZD1613 (Dose 9) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1. |
| Part A3 (SAD): AZD1613 (Dose 10) SC or IV (Japanese) | EXPERIMENTAL | Japanese participants will receive a single dose of AZD1613 (Dose 10) or matching placebo to AZD1613 as SC injection or IV infusion on Day 1. |
| Part B (MAD): AZD1613 (Dose 11) SC or IV | EXPERIMENTAL | Participants will receive multiple doses of AZD1613 (Dose 11) or matching placebo to AZD1613 as SC injection or IV infusion on Days 1, 29 and 57. |
| Part B (MAD): AZD1613 (Dose 12) IV | EXPERIMENTAL | Participants will receive multiple doses of AZD1613 (Dose 12) or matching placebo to AZD1613 as an IV infusion on Days 1, 29 and 57. |
| Part B (MAD): AZD1613 (Dose 13) IV | EXPERIMENTAL | Participants will receive multiple doses of AZD1613 (Dose 13) or matching placebo to AZD1613 as an IV infusion on Days 1, 29 and 57. |
| Name | Type | Description |
|---|---|---|
| AZD1613 | DRUG | AZD1613 will be administered as either SC injection or IV infusion on Day 1 in Part A and on Days 1, 29 and 57 in Part B of the study. |
| Placebo | DRUG | Placebo will be administered as either SC injection or IV infusion on Day 1 in Part A and Days 1, 29 and 57 in Part B of the study. |
Inclusion Criteria: 1. Healthy males and females of non-childbearing potential with suitable veins for cannulation or repeated venipuncture. 2. Negative pregnancy test at screening and admission (females only). 3. Females of non-childbearing potential confirmed by postmenopausal status or irreversi...