ISRCTN12950872进行中（未招募）1 期
A Phase Ia, Randomized, Investigator- and Subject-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single-Ascending Doses of RO7490677 in Healthy Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged =18 and =65 years at the time of signing the Informed Consent Form (ICF)
- •2. Body mass index (BMI) =18 and =32 kg/m² at screening
- •3. Weight =45 and =100 kg at screening
- •4. Clinical laboratory evaluations (not including lymphocyte subsets) at screening and on Day -1 within the reference range for the test laboratory unless deemed not clinically significant by the investigator
- •5. Ability to restrict alcohol intake (=2 servings of alcohol per day, where: one serving is 12 ounces of beer, 5 ounces of wine, 1.5 ounces of spirits, or equivalent), to refrain from the use of tobacco or nicotine products (smoking/vaping), and to refrain from illicit drug use during the study
- •6. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
- •7. For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom and agree to refrain from donating sperm
排除标准
- •1. Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 8 weeks after the final dose of the study drug
- •2. Major surgery within 8 weeks prior to screening, or planned major surgery during the study or planned within 3 months after the dose of study drug
- •3. History or clinical manifestations of significant metabolic, hepatic, renal, pulmonary, cardiovascular, haematologic, gastrointestinal, urologic, neurologic, or psychiatric disorders, as determined by the investigator
- •4. History of serious or uncontrolled hypertension or treatment with antihypertensive medications
- •5. History of malignancy within 5 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, or Stage I uterine cancer
- •6. History of severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies
- •7. Treatment with any immunosuppressive medication within 30 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug
- •8. Donation of blood or plasma from 30 days prior to screening through study completion or end of treatment (ET), inclusive
- •9. Use of a non-biologic investigational drug or participation in an investigational study with a non-biologic drug within 30 days or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug
- •10. Use of biologic investigational therapy or participation in an investigational study involving biologic therapy within 3 months or 5 drug-elimination half-lives, whichever is longer, prior to initiation of study drug
- •11. Use of tobacco or nicotine products including electronic cigarettes (i.e. vaping) within 3 months of screening, as indicated by medical history or urine cotinine levels
- •12. Positive for hepatitis C virus (HCV) antibody and RNA, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody at screening
- •13. Positive for coronavirus (COVID-19) infection at screening and Day -1
- •14. Positive for tuberculosis (TB) during screening or within 3 months prior to screening
- •15. History of or currently active primary or secondary immunodeficiency
研究者
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