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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02151110 | Phase 1 Single-ascending Dose Study to Evaluate Safety and Tolerability of MEDI4920 in Healthy Adults | PHASE1 | COMPLETED | 59 | — | — | May 27, 2014 | May 9, 2016 | Feb 15, 2019 | 1 | United Kingdom |
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 ...