drugset / Trial / NCT03221179

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7049665 in Healthy Volunteers

NCT03221179 ↗

Phase 1 Completed 49 enrolled Hoffmann-La Roche
RandomizedSequentialTriple-blindTreatment

Summary

The primary objective of this study is to evaluate the safety and tolerability of single ascending doses of subcutaneous (SC) injections of RO7049665 in healthy volunteers. In addition, pharmacokinetics (PK) of RO7049665, the effects of single doses of RO7049665 on regulatory T-cells as well as the single dose immunogenicity of RO7049665 will be evaluated. This trial plans to evaluate approximately seven single dose-levels of RO7049665 or matching-placebo during dose-escalation in approximately 40 participants.

Timeline

Start
2017-07-10
Primary completion
2019-07-05
Completion
2019-07-05

Drugs

EvaluationDrugModalityDoseRoute
Subject MELREDABLEUKIN ALFA Protein / enzyme biologic 1.5 ug Subcutaneous

Indications

No indication recorded.