drugset
drugset / Trial / NCT04324268

A Study to Evaluate Safety, Tolerability, and Bioavailability of Subcutaneous Lirentelimab (AK002) in Adult Healthy Volunteers

NCT04324268 ↗

Phase 1 Completed 66 enrolled Allakos Inc.
RandomizedSequentialQuadruple-blindOther

Summary

This is a Phase 1, single-center study to evaluate safety, tolerability, and bioavailability of subcutaneously administered lirentelimab (AK002) in adult healthy volunteers. Subjects will receive a single dose of intravenous AK002 or subcutaneous lirentelimab (AK002) assigned in a double-blind, randomized fashion.

Timeline

Start
2020-03-23
Primary completion
2021-02-10
Completion
2021-02-10

Drugs

EvaluationDrugModalityDoseRoute
Subject lirentelimab Monoclonal antibody 0.3 mg/kg Subcutaneous
Subject lirentelimab Monoclonal antibody 1 mg/kg Subcutaneous
Subject lirentelimab Monoclonal antibody 3 mg/kg Subcutaneous
Subject lirentelimab Monoclonal antibody 5 mg/kg Subcutaneous
Subject lirentelimab Monoclonal antibody 300 mg Subcutaneous
Subject lirentelimab Monoclonal antibody 450 mg Subcutaneous

Indications

No indication recorded.