ACTRN12621001161819已完成1 期
A single center, randomized, double-blind and placebo-controlled phase 1 study to evaluate the safety and tolerability, pharmacokinetics/pharmacodynamics, and immunogenicity of single and multiple ascending subcutaneous doses of RS2102 in healthy adult subjects
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 56
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 55 Years（—）
- 性别
- All
入选标准
- •1.Subject is a healthy adult subject, male or female, 18 to 55 years of age (inclusive) at the time of informed consent.
- •2.Subject has a body mass index (BMI equal to weight/height squared) between 18 and 28 kg/m2 (inclusive), and weight of: male greater than or equal to 50 kg and female greater than or equal to 48 kg.
- •3.Good overall health judged by investigator based on the results of medical history, physical examination, vital signs, laboratory tests, 12-lead ECG, and chest radiography at screening.
- •4.All female or male subjects and their partners of childbearing potential must be willing to follow contraception requirements as per protocol and all female and male subjects who have egg or sperm donation plan must follow egg or sperm donation requirements.
- •5.Subject is willing and able to comply with the scheduled visits and treatment plan, laboratory testing and other study procedures.
- •6.Subject is capable of providing a signed and dated informed consent form (ICF) indicating the subject has been informed of all pertinent aspects of the study described in ICF.
排除标准
- •1)Suspected allergy to the study drug (including IL-2 and polyethylene glycol) or any component of the study drug, or history of anaphylaxis or severe allergic reaction to any drug, food, toxin or other contact exposure per PI discretion.
- •2)Subject with a history of malignant tumor (except for subjects with non-melanoma skin cancer that was cured more than 2 years ago and cervical intraepithelial neoplasia that was cured more than 5 years ago).
- •3)Subjects who had undergone any surgery in the previous 3 months prior to screening, or subject has not recovered from prior surgery as judged by investigators, or plan to receive the operation during the study and within 1 month after completing all study visits.
- •4)Subject with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine, or hematological abnormalities, which is considered by the investigator to potentially impact the study results or affect absorption, distribution, metabolism and excretion of drug or places the subjects at unnecessary risk.
- •5)Active tuberculosis indicated by clinical symptoms, signs, laboratory tests or chest X-ray; latent tuberculosis indicated by T-spot or Quanti-FERON TB test;
- •6)Subject has investigator judged clinically significant infections within 1 month prior to screening, including acute and chronic infections such as abscess, furuncle, carbuncle and other local infections, respiratory tract infections, urinary and reproductive infections, systemic infections, etc. (Minor skin or respiratory infections that have completely resolved even within 1 month are acceptable at the discretion of the investigator).
- •7)Subject with any autoimmune diseases or immune dysfunction at screening.
- •8)Subject participated in any clinical trial of drug or medical device within 2 months prior to screening (or 5 half-lives of drug, whichever is longer).
- •Subject who is receiving or has a history of receiving any of the following medications:
- •9)Use of prescription drug within 14 days prior to baseline or during the study (except for hormonal contraception, topical medications at the discretion of the investigator, brief use of medications that are not expected to interfere with safety or data quality at the discretion of the Principal Investigator and Sponsor).
- •10)Use of over-the-counter drugs, including natural health products (brief use of a supplement in this period that is not expected to interfere with safety or data may be allowed at the discretion of the Principal Investigator and Sponsor) within 14 days prior to baseline, with the exception of occasional use of paracetamol (up to 2 g daily), ibuprofen, or regular doses of vitamins.
- •11)Subject who has received any live vaccine within 1 month prior to screening or need to receive live vaccine during the study (including 30 days after the last dose of study drug).
- •Subject who meets any of the following laboratory endpoints in screening or baseline examination:
- •12)QTc greater than 450 ms or other significant ECG abnormalities with clinical significance as judged by the investigator.
- •13)White blood cell count, neutrophil count, lymphocyte count or hemoglobin in hematology out of the normal reference range and is judged as clinically significant by the investigator.
- •14)Alanine aminotransferase (ALT) greater than 1.5 times the upper limit
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