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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT01566877 | A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7288 in Healthy Adult Volunteers | PHASE1 | COMPLETED | 40 | — | — | May 1, 2013 | Jan 1, 2014 | May 7, 2014 | 1 | United States |
| 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...