ACTRN12623001199606招募中1 期
A randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of FB102 after single and multiple ascending dose administrations in healthy participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 80
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 60 Years（—）
- 性别
- All
入选标准
- •1. Men and women ages 18 to 60 years old, inclusive, at screening.
- •2. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at screening.
- •3. Weight greater than or equal to 50 kg and less than or equal to 100kg for men and greater than or equal to 45 kg and less than or equal to 95kg for women.
- •4. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
- •5. Willing and able to understand and sign the participant informed consent form (PICF).; 1. Men and women ages 18 to 60 years old, inclusive, at screening.
- •2. Body mass index (BMI) between 18.0 and 32.0 kg/m2, inclusive, at screening.
- •3. Weight greater than or equal to 50 kg and less than or equal to 100kg for men and greater than or equal to 45 kg and less than or equal to 95kg for women.
- •4. Good physical and mental health on the basis of medical history, physical examination, clinical laboratory, ECG, and vital signs, as judged by the Investigator.
- •5. Willing and able to understand and sign the participant informed consent form (PICF).
排除标准
- •1. History of any clinically significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies, significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), immunosuppressive conditions or medications, recent or recurrent infections, or any other clinically significant disease, as assessed by the Investigator. Basal cell or squamous cell carcinoma of the skin that has been fully excised and is considered cured is acceptable.
- •2. Any other medical condition or social circumstance, which in the opinion of the Investigator, would impede compliance with or hinder completion of the study.; 1. History of any clinically significant cardiovascular, hepatic, renal, pulmonary, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, metabolic, psychological, musculoskeletal disease or malignancies, significant allergies (except for untreated, asymptomatic seasonal allergies at the time of dosing), immunosuppressive conditions or medications, recent or recurrent infections, or any other clinically significant disease, as assessed by the Investigator. Basal cell or squamous cell carcinoma of the skin that has been fully excised and is considered cured is acceptable.
- •2. Any other medical condition or social circumstance, which in the opinion of the Investigator, would impede compliance with or hinder completion of the study.
研究者
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