Status:
COMPLETED
Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Healthy Adult Subjects
Lead Sponsor:
I-Mab Biopharma US Limited
Conditions:
Healthy Adult Subjects
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 a...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2019
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT03794180
Start Date
March 18 2019
End Date
September 5 2019
Last Update
December 18 2019
Active Locations (1)
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1
Pharmaron
Baltimore, Maryland, United States, 21201