NCT03794180已完成1 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Safety Profile: AEs
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
TJ003234
Experimental
0.3 mg/kg, 1 mg/kg, 3 mg/kg, 10 mg/kg via single IV infusion
干预措施: TJ003234 (Drug)
Placebo
Placebo Comparator
0 mg/kg via single IV infusion
干预措施: Placebo (Drug)
结局指标
主要结局
Safety Profile: AEs
时间窗: Up to 85 days after study drug administration
Incidence of Adverse Events (AEs)
Maximum Tolerated Dose
时间窗: Up to 85 days after study drug administration
Determine Maximum Tolerated Dose of TJ003234
次要结局
- Pharmacokinetic (PK) Parameters: AUC∞(Up to 85 days after study drug administration)
- Pharmacokinetic (PK) Parameters: Tmax(Up to 85 days after study drug administration)
- Pharmacokinetic (PK) Parameters: CL(Up to 85 days after study drug administration)
- Pharmacokinetic (PK) Parameters: Cmax(Up to 85 days after study drug administration)
- Pharmacokinetic (PK) Parameters: T1/2(Up to 85 days after study drug administration)
- Anti-drug antibodies (ADA)(Up to 85 days after study drug administration)
研究者
研究点 (1)
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