Approval Probability
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Adjusted LOA
ML Risk
MEDI9314 · 1 trial · 2 indications
An adverse event is any unfavourable and unintended signs (including abnormal laboratory findings), symptoms, or diseases temporally associated with use of medicinal product, whether or not considered related to medicinal product. Serious adverse event is any AE that resulted in death, life-threatening, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, is a congenital anomaly/birth defect in offspring of a study participant, is an important medical event that may jeopardize the participant or may require medical intervention. TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug and up to Day 240.
TEAEs observed in participants with clinically significant ECG abnormalities were reported.
Vital sign parameters included blood pressure, heart rate, and temperature. TEAEs observed in participants with clinically significant vital signs abnormalities were reported.
Adverse events observed in participants with clinically significant physical abnormalities were assessed.
An abnormal laboratory finding which required an action or medical intervention by the investigator, or a finding judged by the investigator as medically significant should be reported as an adverse event. Laboratory evaluation (haematology, serum chemistry and urinalysis) of blood and urine samples were performed.
Adverse events of special interest observed in participants with clinically significant injection site reaction were assessed.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | single dose of MEDI9314 or placebo |
| Cohort 2 | EXPERIMENTAL | single dose of MEDI9314 or placebo |
| Cohort 3 | EXPERIMENTAL | single dose of MEDI9314 or placebo |
| Cohort 4 | EXPERIMENTAL | single dose of MEDI9314 or placebo |
| Japanese Cohort | EXPERIMENTAL | single dose of MEDI9314 or placebo |
| Cohort 5 | EXPERIMENTAL | single dose of MEDI9314 or placebo |
| Name | Type | Description |
|---|---|---|
| MEDI9314 | DRUG | single dose of MEDI9314 |
| placebo | DRUG | single dose of placebo |
Inclusion Criteria: 1. Written informed consent. 2. Age 18 through 50 years at the time of screening. 3. Female subjects must be of non-childbearing potential. 4. Nonsterilized males who are sexually active with a female partner of childbearing potential must use condom and spermicide. 5. Body mass...
MEDI9314 is an investigational small molecule developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial evaluating its safety and tolerability as a single ascending dose in healthy adult subjects. The specific disease or condition it is intended to treat has not been disclosed.
MEDI9314 is being developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca sponsored the Phase 1 trial of the compound. No partnership or licensing arrangement for MEDI9314 has been announced.
MEDI9314 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are currently listed. The compound has not been approved by the FDA and remains investigational.
MEDI9314 has been evaluated in one completed Phase 1 trial, NCT02669667, titled Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects. The randomized, double-blind, controlled study enrolled 44 healthy adult participants across the United States and the United Kingdom.
The Phase 1 trial NCT02669667 was a randomized, double-blind, controlled study of a single ascending dose of MEDI9314. It enrolled 44 healthy volunteers of all sexes, aged 18 years and older, at sites in the United States and the United Kingdom. The trial has been completed.