NCT03794180

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

First-in-Human, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of TJ003234 (Anti-Granulocyte-macrophage Colony-stimulating Factor (GM-CSF) Monoclonal Antibody) in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: I-Mab Biopharma US Limited · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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).

Conditions

• Healthy Adult Subjects

Interventions

Type	Name	Description
DRUG	TJ003234	Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline
DRUG	Placebo	Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline

Timeline

• Start date: 2019-03-18
• Primary completion: 2019-09-05
• Completion: 2019-09-05
• First posted: 2019-01-04
• Last updated: 2019-12-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study