A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of CBP-201 Administered to Healthy Adult Subjects

Connect Biopharma Australia Pty Ltd0 个研究点目标入组 40 人开始时间: 2018年5月4日最近更新: 2019年1月28日

适应症

试验速览

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•Healthy male and female subjects age between 18 and 65 years, inclusive
•Able to provide written informed consent prior to any study procedures
•Male subjects must abstain from heterosexual activities or agree to use an adequate method of contraception through 90 days after the dose of study drug. Heterosexual women of child-bearing potential (WOCBP) who are sexually active must be willing to use effective contraception. Effective contraception includes:
•Using a condom, and a diaphragm or cervical cap
•Oral contraceptives (The Pill)
•Depot or injectable birth control or implantable contraception (e.g. Implanon)
•IUD (intrauterine device)
•Documented evidence of surgical sterilization at least 6 months prior to screening visit. i.e., tubal ligation or hysterectomy for women or vasectomy for men.

•Subjects presenting with any of the following will not be included in the study:
•Any clinically significant laboratory abnormalities on screening as determined by the investigator
•Acute illness or history of illness, which in the opinion of the investigator could pose a threat or harm to the subject or obscure interpretation of laboratory tests or interpretation of study data. Subjects with chronic illness such as diabetes, heart disease, renal insufficiency, asthma, chronic pain, an immunocompromised state or substance abuse are specifically excluded
•Positive pregnancy test
•Women who are pregnant, considering becoming pregnant or nursing
•Positive testing for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C antibodies (HCV)
•Positive Quantiferon Gold Test
•Positive screen for illicit substances and alcohol
•Subjects with known allergy or hypersensitivity to any components of the study drug
•Subjects who have received a live vaccine within 3 months of study entry
•Subjects regularly taking medication for a chronic condition. However, hormonal contraception and paracetamol, less than 2g per day, is allowed
•Subjects currently participating in an interventional study must wash out of the previous study for at least 30 days or 5 half-lives of the study drug, whichever is longer
•Planned surgical procedure during the study participation period

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