A Randomized, Double-blinded, Placebo-controlled, Single-dose, Dose-escalation study of Lenzilumab in Healthy Korean Subjects

Telcon RF Pharmaceuticals0 个研究点目标入组 20 人开始时间: 待定最近更新: 2022年10月24日

适应症

试验速览

阶段: 未知
状态: 已完成
发起方
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional Study

入排标准

年龄范围: 19(Year) 至 45(Year)（—）
性别: All

入选标准

•1) Healthy adults aged 19 to 45 at the time of screening tests
•2) Those with a body mass index (BMI) of 18.5 kg/m2 to 29.9 kg/m2 at the time of screening test
•? Body mass index (BMI) = Weight (kg)/[Height (m)]2
•3) After hearing sufficient explanation of this clinical trial and fully understanding it, a person who voluntarily decided to participate and agreed in writing to comply with precautions
•4) A person who is suitable for the clinical trial of this test when determining a investigator through physical examination, clinical laboratory examination, or examination by interview

排除标准

•1) A person with a history of diseases or history that are believed to affect clinical trials such as mediastinal, kidney, nervous, immune, respiratory, digestive, endocrine, blood•tumor, cardiovascular, urological, and psychiatric diseases
•2) A person whose clinical laboratory test results are not suitable for participation in this test, or who shows clinically significant findings in ECG, chest X-ray
•- WBC = 3.5×10^9/L or absolute neutrophil = 2.0×10^9/L
•- Hb < 13.0 or > 16.0 gm/dL
•- Creatinine = 2 mg/dL
•- Total bilirubin = 2 mg/dL
•- ALT/AST = 2 ULN (Upper limit of normal)
•- Significant findings in Urine dipstick
•- QTc (Bazett) > 450 ms (Male), 460 ms (Female)
•- QRS interval > 120 ms or PR interval > 210 ms
•- Acute or chronic lung disease findings in chest X-ray
•- Oxygen saturation and abnormal findings of DLCO
•- A person who is positive as a result of a serum test (hepatitis B, hepatitis C, HIV, syphilis test)
•3) A person who has a history of hypersensitivity or clinically significant hypersensitivity to drugs including the same type of defense antibodies and immunoglobulin and other drugs (aspirin, antibiotic, etc.)
•4) A person who have been tested positive for COVID-19. A person who has been treated for COVID-19 or has been given a COVID-19 vaccine within 3 months prior to the scheduled date of administration of the investigational product
•5) A person who has a history of administering vaccines within 1 month of the scheduled date of investigational product for clinical trials
•6) Current smokers who have smoked more than 10 cigarettes a day
•7) Those who have a drinking history of more than 4 units a day (1 unit = 10g of pure alcohol, 300mL of beer, 1 glass of wine, 1 glass of soju) or cannot abstain from drinking from 3 days before the scheduled date of investigational product administration to the hospitalization period
•8) A person who has a history of drug abuse or has tested positive for an abused drug in a urine screening test
•9) Those who have taken prescription drugs, general medicines, health functional foods, vitamin preparations, or herbal medicines within 2 weeks before the scheduled date of administration of investigational product, or those who are expected to take them
•10) Those who participated in other clinical trials within 6 months before the first scheduled date of administration of investigational product
•11) A person who donated whole blood within 3 months prior to the expected first dose date or donated ingredients within 1 month prior to the expected first dose date, or received a blood transfusion within 1 month prior to the expected first dose date
•12) Those who are unable to use medically recognized double contraceptives or medically acceptable contraceptives by him/herself, the spouse or the partner up to 6 months after administration of investigational product, and who disagree not to donate sperm until that period
•? Medically acceptable contraceptive method
•- The use of intrauterine devices with proven pregnancy failure rates in spouses (or partners) or themselves
•- Use of both men and women's methods of blocking contraception and a spermicide at the same time
•- Surgery of the person or partner(vasectomy, tubectomy/ligation, hysterectomy)
•13) Pregnant women or lactating women
•14) A person who determines that the investigator is inappropriate to participate in clinical trials due to oth

研究者

发起方

Telcon RF Pharmaceuticals

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