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

Study Overview
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Brief Summary
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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).

Official Title
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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

Conditions
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Healthy Adult Subjects

Intervention / Treatment
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* Drug: TJ003234
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TJ003234<br>0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg via single IV infusion | Drug: TJ003234<br>* Brownish-yellow liquid containing TJ003234, a recombinant humanized immunoglobulin (Ig) G1 monoclonal antibody diluted with normal saline<br>|
| Placebo Comparator: Placebo<br>0 mg/kg via single IV infusion | Drug: Placebo<br>* Colorless to slightly brownish-yellow liquid without TJ003234 diluted with normal saline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Profile: AEs | Incidence of Adverse Events (AEs) | Up to 85 days after study drug administration | 
| Maximum Tolerated Dose | Determine Maximum Tolerated Dose of TJ003234 | Up to 85 days after study drug administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic (PK) Parameters: Tmax | Time of peak concentration (Tmax) | Up to 85 days after study drug administration | 
| Pharmacokinetic (PK) Parameters: Cmax | Maximal Concentration (Cmax) | Up to 85 days after study drug administration | 
| Pharmacokinetic (PK) Parameters: T1/2 | Investigational product (IP) half-life (T1/2) | Up to 85 days after study drug administration | 
| Pharmacokinetic (PK) Parameters: CL | Investigational Product (IP) Clearance (CL) | Up to 85 days after study drug administration | 
| Pharmacokinetic (PK) Parameters: AUC∞ | Area under the curve from time zero extrapolated to infinity (AUC∞) | Up to 85 days after study drug administration | 
| Anti-drug antibodies (ADA) | Incidence and concentration of anti-drug antibodies | Up to 85 days after study drug administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anti-GM-CSF agents, GM-CSF/GM-CSFR (GM-CSF receptor) antibody, colony-stimulating factor 2, monoclonal antibody