Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AZD0543 · 1 trial · 1 indication
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
To assess the safety of AZD0543 administered as a single IM or IV dose compared to placebo
| Arm | Type | Description |
|---|---|---|
| Cohort 1: Low Dose AZD0543 | EXPERIMENTAL | Participants will receive a single AZD0543 dose. |
| Cohort 1: Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo. |
| Cohort 2: Medium Dose AZD0543 | EXPERIMENTAL | Participants will receive a single AZD0543 dose. |
| Cohort 2: Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo. |
| Cohort 3: High Dose AZD0543 | EXPERIMENTAL | Participants will receive a single AZD0543 dose. |
| Cohort 3: Placebo | PLACEBO_COMPARATOR | Participants will receive a single dose of placebo. |
| Name | Type | Description |
|---|---|---|
| AZD0543 | BIOLOGICAL | Sterile solution for injection or infusion administered as a single IM or IV dose on Day 1. |
| Placebo | OTHER | Volume-matched 0.9% (w/v) sterile saline solution for injection or infusion administered as a single IM or IV dose on Day 1. |
Key Inclusion Criteria: * Age 18 to 55 years * Body weight ≥ 45 kg and ≤ 110 kg and BMI within the range ≥ 18.0 kg/m2 to ≤ 30 kg/m2 Key Exclusion Criteria: * Hypersensitivity to IMP/components * Severe adverse reaction/hypersensitivity to other mAbs * Acute fever/illness/infection within 3 days o...