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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06103877 | A Placebo-controlled Safety and Tolerability Study of Intravenous (IV) and Subcutaneous (SC) AZD1163 in Healthy Volunteers | PHASE1 | COMPLETED | 108 | — | — | Nov 1, 2023 | Jan 13, 2026 | Jan 27, 2026 | 3 | United States, Germany |
To assess the safety and tolerability of single and multiple ascending doses of AZD1163 following IV or SC administration.
| Arm | Type | Description |
|---|---|---|
| Part 1 Cohort 1 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 2 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 3 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 4 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 5a SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 5b SAD | ACTIVE_COMPARATOR | Participants will receive SC injection of AZD1163 on Day 1. |
| Part 1 Cohort 6 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 7 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Cohort 8 SAD | ACTIVE_COMPARATOR | Participants will receive IV infusion of AZD1163 on Day 1. |
| Part 1 Pooled Placebo SAD IV | PLACEBO_COMPARATOR | Participants will receive matching IV infusion of placebo on Day 1. |
| Part 1 Placebo SAD SC | PLACEBO_COMPARATOR | Participants will receive matching SC injection of placebo on Day 1. |
| Part 1 Cohort 9 SAD (Chinese Participants) | ACTIVE_COMPARATOR | Participants will receive SC injection of AZD1163 on Day 1. |
| Part 1 Placebo SAD (Chinese Participants) | PLACEBO_COMPARATOR | Participants will receive matching SC injection of placebo on Day 1. |
| Part 2 Cohort 1 MAD (Global) | ACTIVE_COMPARATOR | Participants will receive SC injection of AZD1163 on Days 1 and 15. |
| Part 2 Cohort 2 MAD (Global) | ACTIVE_COMPARATOR | Participants will receive SC injection of AZD1163 on Days 1 and 15. |
| Part 2 Placebo MAD (Global) | PLACEBO_COMPARATOR | Participants will receive matching SC injection of placebo on Days 1 and 15. |
| Part 2 Cohort 3 MAD (Chinese Participants) | ACTIVE_COMPARATOR | Participants will receive SC injection of AZD1163 on Days 1 and 15. |
| Part 2 Cohort 4 MAD (Japanese participants) | ACTIVE_COMPARATOR | Participants will receive SC injection of AZD1163 on Days 1 and 15. |
| Part 2 Placebo MAD (Chinese participants) | PLACEBO_COMPARATOR | Participants will receive matching SC injection of placebo on Days 1 and 15. |
| Part 2 Placebo MAD (Japanese participants) | PLACEBO_COMPARATOR | Participants will receive matching SC injection of placebo on Days 1 and 15. |
| Name | Type | Description |
|---|---|---|
| AZD1163 | BIOLOGICAL | In Part 1, Participants will receive AZD1163 through IV infusion or SC injection on Day 1. In Part 2, participants will receive AZD1163 through SC injection on Days 1 and 15. |
| Placebo | OTHER | In Part 1, Participants will receive matching placebo through IV infusion or SC injection on Day 1. In Part 2, participants will receive matching placebo through SC injection on Days 1 and 15. |
Inclusion Criteria: * Healthy male and female participants with suitable veins for cannulation or repeated venipuncture * All females must have a negative pregnancy test * Females of childbearing potential must not be lactating and, if heterosexually active, agree to taking approved method/s of con...