Approval Probability
TA Base Rate
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 being studied for safety in healthy subjects. It is in Phase 1 clinical development, with a completed trial evaluating its safety and tolerability as a single ascending dose. It is not approved for any indication.
MEDI9314 is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN. The company is conducting clinical trials to evaluate the safety of this investigational small molecule.
MEDI9314 is in Phase 1 clinical development. A Phase 1 trial has been completed, which studied the safety and tolerability of single ascending doses in healthy subjects. The drug is investigational and has not been approved by regulatory authorities.
MEDI9314 has one completed clinical trial, identified as NCT02669667, titled 'Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects.' This Phase 1 study enrolled 44 participants in the United States and United Kingdom and was a randomized, double-blind, controlled trial.
MEDI9314 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. A Phase 1 trial has been completed to evaluate its safety and tolerability in healthy subjects, but it has not received regulatory approval for any use.