Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MEDI-557 · 1 trial · 1 indication
The occurrence of AEs and SAEs
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Placebo |
| MEDI-557 low-dose | ACTIVE_COMPARATOR | - |
| MEDI-557 high-dose | ACTIVE_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo |
| MEDI-557 | DRUG | MEDI-557 low-dose |
Inclusion Criteria: * 18-45 years * written informed consent obtained from subject prior to performing any protocol related procedures * healthy by medical history and physical exam * females of child-bearing potential must use 2 effective methods of birth control for 14 days prior to 1st dose and ...
MEDI-557 is an investigational small molecule being developed for Respiratory Syncytial Virus, or RSV, an infectious disease of the respiratory tract. It has been studied in healthy adult volunteers rather than in patients with active RSV disease. AstraZeneca PLC is the developer.
MEDI-557 is being developed by AstraZeneca PLC, which trades on the Nasdaq under the ticker AZN. The company sponsored the Phase 1 adult dosing study of the compound. No other developer or partnership for MEDI-557 is disclosed.
MEDI-557 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The program remains investigational, and MEDI-557 has not been approved by the FDA for any indication.
MEDI-557 has been evaluated in one completed Phase 1 trial, NCT01562938, titled MEDI-557 Adult Dosing. The study enrolled 42 healthy adult volunteers aged 18 years and older in the United States. It was randomized, double blind, and placebo controlled.
No. MEDI-557 is an investigational agent in Phase 1 development and has not been approved by the FDA. Its only recorded clinical study, NCT01562938, is completed, and no active trials of MEDI-557 are ongoing.