drugset / Trial / NCT01566877
A Study to Assess the Safety, Tolerability and Pharmacokinetics of AVI-7288 in Healthy Adult Volunteers
Phase 1
Completed
40 enrolled
Sarepta Therapeutics, Inc.
United States Department of Defense · collab
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this study is to evaluate the safety and tolerability of healthy male and female subjects with intravenous (IV) infusions of AVI 7288 compared to matched placebo in and to evaluate the pharmacokinetics (PK).
Timeline
- Start
- 2013-05
- Primary completion
- 2014-01
- Completion
- 2014-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | AVI-7288 | Antisense oligonucleotide | 1 mg/kg | Intravenous |
| Comparator | AVI-7288 | Antisense oligonucleotide | 4 mg/kg | Intravenous |
| Comparator | AVI-7288 | Antisense oligonucleotide | 8 mg/kg | Intravenous |
| Comparator | AVI-7288 | Antisense oligonucleotide | 12 mg/kg | Intravenous |