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

NCT03794180 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2019-12-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • I-Mab Biopharma US Limited

    lead INDUSTRY

Principal Investigators

  • Claire Xu, MD, PhD · I-Mab Biopharma

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-03-18
Primary Completion
2019-09-05
Completion
2019-09-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03794180 on ClinicalTrials.gov