A first-in-human, randomized, participant-blinded, placebo controlled, single ascending dose study to investigate the safety, tolerability and pharmacokinetics of bispecific antibody in healthy volunteers

Sato Mika0 个研究点目标入组 56 人开始时间: 2023年11月9日最近更新: 2024年4月1日

适应症

试验速览

暂无简介。

•Able and willing to provide written informed consent.
•- Healthy male or non-childbearing potential female participants 18 to 55 years of age, inclusive, at the time of screening, and in good health as determined by past medical history, physical examination, vital signs, electrocardiogram, and laboratory tests at screening and baseline.
•- Weigh at least 45.0 kg (female) and 50.0 kg (male) with a body mass index (BMI) within the range of 18.5- 29.9kg/m2

•- Significant illness, including infectious diseases that has not resolved within 2 weeks prior to baseline, or positive SARS-CoV-2 test result at baseline, or contact with a known case of COVID-19 infection in the 2 weeks prior to baseline.
•- Evidence of active or latent Tuberculosis (TB) infection, as determined by T-Spot test at screening.
•- Use of other investigational drugs within the last 30 days or 5 half-lives of the other drugs prior to initial dosing, whichever is longer
•- Use of any prescription drugs, over-the-counter (OTC) medications, herbal supplements within the last 4 weeks prior to initial dosing.
•- Smokers (use of tobacco/nicotine products within 3 months of dosing).

发起方

Sato Mika