drugset
drugset / Trial / NCT03794180

Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects

NCT03794180 ↗

Phase 1 Completed 32 enrolled I-Mab Biopharma US Limited
RandomizedParallel-groupTriple-blindTreatment

Summary

TJ003234RAR101 is a first-in-human (FIH), single-center, randomized, double-blind, placebo-controlled, single ascending dose study of TJ003234 in healthy adults to determine whether TJ003234 is safe and tolerated when administered as an intravenous (IV) infusion and to determine the maximum dose tolerated (MTD).

Timeline

Start
2019-03-18
Primary completion
2019-09-05
Completion
2019-09-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Plonmarlimab Monoclonal antibody 0.3 mg/kg Intravenous
Subject Plonmarlimab Monoclonal antibody 1 mg/kg Intravenous
Subject Plonmarlimab Monoclonal antibody 3 mg/kg Intravenous
Subject Plonmarlimab Monoclonal antibody 10 mg/kg Intravenous

Indications

No indication recorded.