Pharmaron
Baltimore, Maryland, 21201, United States
NCT Number: NCT03794180
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).
Looking for future studies?
Notify Me18 year–70 year
All sexes
Interventional
Phase 1
Baltimore, Maryland, 21201, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline
Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline
Time frame: Up to 85 days after study drug administration
Incidence of Adverse Events (AEs)
Time frame: Up to 85 days after study drug administration
Determine Maximum Tolerated Dose of TJ003234
Time frame: Up to 85 days after study drug administration
Time of peak concentration (Tmax)
Time frame: Up to 85 days after study drug administration
Maximal Concentration (Cmax)
Time frame: Up to 85 days after study drug administration
Investigational product (IP) half-life (T1/2)
Time frame: Up to 85 days after study drug administration
Investigational Product (IP) Clearance (CL)
Time frame: Up to 85 days after study drug administration
Area under the curve from time zero extrapolated to infinity (AUC∞)
Time frame: Up to 85 days after study drug administration
Incidence and concentration of anti-drug antibodies
I-Mab Biopharma US Limited
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04481750
Healthy Adult Subjects
Osaka, Japan
View Trial DetailsNCT04493281
Healthy Adult Subjects
Tokyo, Japan
View Trial DetailsNCT04776135
Healthy Adult Subjects
Tokyo, Toshima-ku, Japan
View Trial DetailsNCT04029090
Healthy Adult Subjects
Tokyo, Japan
View Trial Details