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

Completed · Phase 1 · Has a placebo group

Conditions studied: Healthy Adult Subjects

In brief

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).

Key facts

Study ID

NCT03794180

Run by

I-Mab Biopharma US Limited

People needed

32

Starts

2019-03-18

Expected to finish

2019-09-05

Last updated by the study team

2019-12-18

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to understand and willing to sign the informed consent form (ICF)
• Healthy subjects 18-70 years of age
• If of childbearing potential, agree to use protocol-specified contraception
• Body mass index (BMI) 19.0-32.0 kg/m\^2
• Blood pressure ≤ 139/89 mm Hg
• Subjects are able to follow the study protocol and complete the trial

You may not qualify if…

• Current use of tobacco or nicotine-containing products or illicit drug use
• History of severe allergic or anaphylactic reaction to a therapeutic drug or severe seasonal allergies
• Any known pulmonary disease
• Use of any prescription, investigational drugs, herbal supplements, or nonprescription drugs within 1 month or 5 half-lives (whichever is longer) prior to study drug administration, or dietary supplements within 1 week prior to study drug administration, unless, in the opinion of the Investigator and Sponsor, the medication will not interfere with the study
• Abnormal hematological and chemistry laboratory values >10% above upper limit of normal (ULN) or >10% below the lower limit of normal (LLN). Absolute neutrophil count (ANC) ≤ 1000 cells/mm\^3
• Use of any biologic drugs in the last 120 days prior to dosing.
• Immunization with a live or attenuated vaccine within 4 weeks prior to study drug administration
• Prior treatment with any biologic anti-GM-CSF or GM-CSF receptor antagonists
• ADA screening positive
• Subjects who have a history of documented autoimmune disease, even if not clinically severe or never treated with systemic steroids or immunosuppressive agents
• A positive alcohol test and/or urine drug screen for substance of abuse at screening or upon check-in to the clinical site

Where it is running

• Pharmaron — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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