Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AVI-7288 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| AVI-7288 | ACTIVE_COMPARATOR | AVI-7288 is a phosphorodiamidate morpholino oligomer with positive charges (PMOplus™) that targets Marburg virus nucleoprotein (NP). AVI-7288 is supplied in 5 mL vials containing 5 mL AVI-7288 at a concentration of 50 mg/mL. The dose levels of AVI-7288 will vary in four cohort's. |
| Placebo | PLACEBO_COMPARATOR | Placebo control consists of approximately 150 mL normal saline solution administered by IV infusion over 30 minutes once a day for 14 days. |
| Name | Type | Description |
|---|---|---|
| AVI-7288 | DRUG | Cohort 1: AVI-7288 at 1 mg/kg IV; Cohort 2: AVI-7288 at 4 mg/kg IV;Cohort 3: AVI-7288 at 8 mg/kg IV; Cohort 4: AVI-7288 at 12 mg/kg IV The amount of AVI-7288 required to administer the required dose will be diluted to a volume of approximately 150 mL with normal saline solution (NSS) and given by IV infusion over 30 minutes once a day for 14 days. Infusions will be administered at approximately the same time each day. |
| Placebo | OTHER | Normal Saline Solution (NSS) |
Inclusion Criteria: A subject must meet all of the following criteria to be eligible for this study. 1.Man or woman 18 to 50 years of age, inclusive, at the time of screening. 2.Body mass index 18 kg/m2 to 35 kg/m2, inclusive, at the time of screening and Check-in (Day -1).3.Good general health (n...
AVI-7288 is an investigational small molecule being developed for Marburg Hemorrhagic Fever, a severe infectious disease. It is currently in Phase 1 clinical development and has not been approved by regulatory authorities.
AVI-7288 is being developed by Sarepta Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol SRPT.
AVI-7288 is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed.
AVI-7288 has one completed clinical trial, NCT01566877, which assessed the safety, tolerability, and pharmacokinetics of the drug in healthy adult volunteers in the United States. The trial enrolled 40 participants.
No, AVI-7288 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Marburg Hemorrhagic Fever.