drugset
drugset / Trial / NCT04815551

A Phase 1 Study of AV-380 in Healthy Subjects

NCT04815551 ↗

Phase 1 Completed 51 enrolled AVEO Pharmaceuticals, Inc.
RandomizedSequentialQuadruple-blindTreatment

Summary

This double-blinded, placebo-controlled, single ascending dose (SAD) study is designed to evaluate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity in healthy subjects of a single dose of AV-380. AV-380 is an immunoglobulin (Ig) G1 monoclonal antibody (mAb) intended to bind circulating human growth differentiation factor 15 (GDF-15), a cytokine involved in cancer-induced cachexia.

Timeline

Start
2021-02-22
Primary completion
2022-01-14
Completion
2022-01-14

Drugs

EvaluationDrugModalityDoseRoute
Subject RILOGROTUG Monoclonal antibody 1 mg/kg Intravenous
Subject RILOGROTUG Monoclonal antibody 2 mg/kg Intravenous
Subject RILOGROTUG Monoclonal antibody 4 mg/kg Intravenous
Subject RILOGROTUG Monoclonal antibody 8 mg/kg Intravenous
Subject RILOGROTUG Monoclonal antibody 13 mg/kg Intravenous
Subject RILOGROTUG Monoclonal antibody 20 mg/kg Intravenous

Indications

hypoproteinemia, hypercatabolic