ACTRN12616000049471已完成1 期
A Double-Blinded, Randomized, Placebo-Controlled, Single AscendingDose (SAD) and Multiple Ascending Dose (MAD) Study to Evaluate theSafety, Tolerability, Pharmacokinetics and Pharmacodynamics of ANB020in Healthy Subjects.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 45 Years（—）
- 性别
- All
入选标准
- •Healthy male and female as determined by a lack of clinically significant medical history, physical examination, ECGs, and clinical laboratory determinations.
排除标准
- •Medical History and Concurrent Diseases:
- •a) Any significant acute or chronic medical illness.
- •b) History of bacterial or viral infections that led to hospitalization and IV antibiotic or antiviral treatment within 3 months prior to screening, or any recent infection requiring antibiotic or antiviral treatment within 4 weeks of Day 1.
- •c) History of recurrent or chronic sinusitis, bronchitis, pneumonia, urinary tract infection (recurrent or chronic infection is 2 episodes within 6 months).
- •d) History of malaria (excluding falciparum).
- •e) History or any evidence of active infection or febrile illness within 7 days of dosing (e.g., bronchopulmonary, urinary, or gastrointestinal).
- •f) Active, or history of, parasitic infections such as, but not exclusively, helminth, protozoa, Trypanosoma cruzi.
- •g) Subjects with a positive quantiFERON (Registered Trademark) test at screening or within 6 months prior to Day 1 will not be eligible for the study.
- •h) Known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosus, polymyalgia rheumatica, giant cell arteritis, Behcet’s disease, dermatomyositis, multiple sclerosis, moderate to severe asthma, or other severe forms of atopy, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a subject requires medical follow-up or medical treatment.
- •i) Any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject’s immune status (e.g., history of splenectomy).
- •j) Presence of any factors that would predispose the subject to develop infection e.g., rectal fissures, poor dentition, open skin lesions, and presence of preexisting skin conditions that increase risks for injection site complications e.g. Behcet’s Disease, Psoriasis, pustular dermatoses.
- •k) Current or recent (within 3 months of study drug administration) gastrointestinal disease.
- •l) Any major surgery within 4 weeks of study drug administration.
- •m) Any gastrointestinal surgery that could impact upon the absorption of study drug.
- •n) Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only).
- •o) Blood transfusion within 4 weeks of study drug administration.
- •p) Inability to tolerate IV or SC drug administration
- •q) Inability to be venipunctured and/or tolerate venous access.
- •r) Previous administration of mAbs
- •s) Smoking more than 10 cigarettes per day.
- •t) Recent (within 6 months of study drug administration) drug or alcohol abuse as defined in DSM V, Diagnostic Criteria for Drug and Alcohol Abuse.
- •u) Any other sound medical, psychiatric and/or social reason as determined by the Investigator.
- •Physical and Laboratory Test Findings:
- •a) Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG or clinical laboratory determinations beyond what is consistent with the target population.
- •b) Alanine aminotransferase (ALT) levels greater than ULN, confirmed by one repeat.
- •c) Total and unconjugated bilirubin greater than ULN, confirmed by one repeat. Subjects with a previously documented diagnosis of Gilbert’s disease who have serum bilirubin less or equal to 3 x ULN may be enrolled.
- •d) Evidence of clinically significant abnormality in urinalysis testing as determined by the Investigator.
- •e) Abnormal c
研究者
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