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 being developed by AstraZeneca PLC (AZN). It is currently in Phase 1 clinical development, studied in healthy volunteers. The drug is not approved and remains under investigation for safety and tolerability.
MEDI4920 is being studied in healthy volunteers as part of early clinical development. Its intended therapeutic use has not been established, as it is still in Phase 1 trials. The drug is not approved for any condition.
MEDI4920 is developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker AZN. AstraZeneca is conducting the clinical development of this investigational monoclonal antibody.
MEDI4920 is in Phase 1 clinical development. A Phase 1 single-ascending dose study has been completed in healthy adults. The drug is investigational and has not received regulatory approval.
MEDI4920 has one completed clinical trial, NCT02151110, a Phase 1 single-ascending dose study evaluating safety and tolerability in healthy adults. The trial enrolled 59 participants in the United Kingdom and was randomized, double-blind, and placebo-controlled.