drugset / Trial / NCT02555085
Single Ascending Doses of BIIB063 in Healthy Volunteers
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The primary objective of the study is to evaluate the safety and tolerability of single ascending intravenous (IV) doses and a single subcutaneous (SC) dose of BIIB063 in healthy volunteers. The secondary objectives of the study are to estimate the PK parameters of single ascending IV doses of BIIB063; to estimate the PK parameters and absolute bioavailability (F) of a single SC dose of BIIB063; and to evaluate the immunogenicity of single ascending doses of BIIB063.
Timeline
- Start
- 2015-09-30
- Primary completion
- 2016-06-01
- Completion
- 2016-06-01
Outcome
Outcome not reported
Stopped: “Clinical study terminated due to preclinical safety findings in non-human primates.”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BIIB063 | Unknown | — | Intravenous |
Indications
No indication recorded.