drugset / Trial / NCT04082754

A Clinical Study to Test the Safety, Exposure, and Pharmacodynamic Markers of CSL311 in Patients With Mild-to-moderate Asthma and in Healthy Volunteers

NCT04082754 ↗

Phase 1 Completed 78 enrolled CSL Behring
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a phase 1, first-in-human (FIH), multi-center, randomized, double-blind, placebo-controlled study of CSL311 in patients with mild-to-moderate asthma. The primary objective of this study is to assess the safety and tolerability of single ascending doses (SAD) and multiple ascending doses (MAD) of CSL311.

Timeline

Start
2019-11-28
Primary completion
2023-11-14
Completion
2023-11-14

Drugs

EvaluationDrugModalityDoseRoute
Subject CSL311 Monoclonal antibody — Intravenous

Indications