drugset / Trial / NCT02555085

Single Ascending Doses of BIIB063 in Healthy Volunteers

NCT02555085 ↗

Phase 1 Terminated 29 enrolled Biogen
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

EvaluationDrugModalityDoseRoute
Subject BIIB063 Unknown — Intravenous

Indications

No indication recorded.