drugset / Trial / NCT03721263

Study of ASLAN004 in Healthy Subjects

NCT03721263 ↗

Phase 1 Completed 44 enrolled ASLAN Pharmaceuticals IQVIA Pty Ltd · collab
NaSingle-groupOpen-labelTreatment

Summary

This is an open-label, two-part, single-center, first in human (FIH), single ascending dose (SAD) study to assess the effects of single doses of ASLAN004 when administered to healthy subjects. The objective of this study is to evaluate the safety, tolerability, and Pharmacokinetics (PK) of ASLAN004 in healthy subjects.

Timeline

Start
2018-10-15
Primary completion
2019-03-27
Completion
2019-06-20

Drugs

EvaluationDrugModalityDoseRoute
Subject ASLAN004 Monoclonal antibody 0.1 mg/kg Intravenous
Subject ASLAN004 Monoclonal antibody 0.3 mg/kg Intravenous
Subject ASLAN004 Monoclonal antibody 1 mg/kg Intravenous
Subject ASLAN004 Monoclonal antibody 3 mg/kg Intravenous
Subject ASLAN004 Monoclonal antibody 10 mg/kg Intravenous
Subject ASLAN004 Monoclonal antibody 20 mg/kg Intravenous
Subject ASLAN004 Monoclonal antibody 75 mg Intravenous
Subject ASLAN004 Monoclonal antibody 150 mg Intravenous
Subject ASLAN004 Monoclonal antibody 300 mg Intravenous
Subject ASLAN004 Monoclonal antibody 600 mg Intravenous

Indications