Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI4920 · 1 trial · 1 indication
An adverse event (AE) is any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening situation (immediate risk of dying); persistent or significant disability or incapacity; congenital anomaly or birth defect in the offspring of a participant who received the study drug. A TEAE is defined as the event with onset after the start of infusion (Day 1) to Day 113 or early discontinuation visit inclusive. The AEs were summarized using Medical Dictionary for Regulatory Activities version 19.0.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. |
| MEDI4920 3 mg | EXPERIMENTAL | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. |
| MEDI4920 10 mg | EXPERIMENTAL | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. |
| MEDI4920 30 mg | EXPERIMENTAL | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. |
| MEDI4920 100 mg | EXPERIMENTAL | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. |
| MEDI4920 300 mg | EXPERIMENTAL | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| MEDI4920 1000 mg | EXPERIMENTAL | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| MEDI4920 3000 mg | EXPERIMENTAL | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Name | Type | Description |
|---|---|---|
| MEDI4920 3 mg | BIOLOGICAL | Participants received single IV dose of MEDI4920 3 milligram (mg) infused on Day 1. |
| MEDI4920 10 mg | BIOLOGICAL | Participants received single IV dose of MEDI4920 10 mg infused on Day 1. |
| MEDI4920 30 mg | BIOLOGICAL | Participants received single IV dose of MEDI4920 30 mg infused on Day 1. |
| MEDI4920 100 mg | BIOLOGICAL | Participants received single IV dose of MEDI4920 100 mg infused on Day 1. |
| MEDI4920 300 mg | BIOLOGICAL | Participants received single IV dose of MEDI4920 300 mg infused on Day 1. |
| MEDI4920 1000 mg | BIOLOGICAL | Participants received single IV dose of MEDI4920 1000 mg infused on Day 1. |
| MEDI4920 3000 mg | BIOLOGICAL | Participants received single IV dose of MEDI4920 3000 mg infused on Day 1. |
| Placebo | OTHER | Participants received single IV dose of placebo matching with MEDI4920 infused on Day 1. |
Inclusion Criteria: * Healthy as determined by a responsible study physician based on medical evaluation * Body weight 40 to 100 kg * Body mass index 19.0 to 30.0 kg/m2 Exclusion Criteria: * History of allergy or sensitivity to Shellfish or protein based antigens * previous immunization with KLH ...
MEDI4920 is an investigational monoclonal antibody developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial in healthy adult volunteers in the United Kingdom. The specific disease indications for MEDI4920 have not been disclosed.
MEDI4920 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. AstraZeneca sponsored the Phase 1 study of MEDI4920 conducted in the United Kingdom.
MEDI4920 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The completed study was a single-ascending dose trial evaluating safety and tolerability in healthy adults.
MEDI4920 has been evaluated in one completed Phase 1 trial, NCT02151110, titled a Phase 1 single-ascending dose study to evaluate safety and tolerability of MEDI4920 in healthy adults. The trial enrolled 59 participants in the United Kingdom and was randomized, double-blind, and placebo-controlled.
MEDI4920 is not approved. It is an investigational monoclonal antibody in Phase 1 clinical development, and its only completed trial was a single-ascending dose study in healthy adult volunteers. No regulatory approval has been granted for MEDI4920.