NL-OMON50099已完成不适用
Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics and pharmacodynamics of monoclonal antibody TB31F in healthy malaria-naïve adults in the Netherlands - Safety, tolerability, and pharmacokinetics and pharmacodynamics of TB31F
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
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
- 年龄范围
- 18 至 99（—）
入选标准
- •* Subject must sign written informed consent to participate in the trial.
- •* Subject is able to understand planned study procedures and demonstrate
- •comprehension of the protocol procedures and knowledge of study by passing a
- •* In the opinion of the investigator, the subject can and will comply with the
- •requirements of the protocol.
- •* Subjects are available to attend all study visits and are reachable by phone
- •throughout the entire study period from day -1 until day 84 (end of study).
- •* The subject will remain within reasonable travelling distance from the study
- •center from day -1 till day +7 after mAb TB31F administration.
- •* Subject is a male or non-pregnant female age * 18 and * 35 years and in good
- •health at time of mAb administration.
- •* Subject agrees to their general practitioner (GP) being informed about
- •participation in the study and agrees to sign a form to request the release by
- •their GP, and medical specialist when necessary, of any relevant medical
- •information concerning possible contra-indications for participation in the
- •study to the investigator(s).
- •* The subject agrees to refrain from blood donation to Sanquin or for other
- •purposes throughout the study period according to current Sanquin guidelines.
- •* Female subjects of non-childbearing potential may be enrolled in the study.
- •All subjects must agree to use continuous adequate contraception until 2 months
- •after completion of the study.
排除标准
- •(Protocol section 4.3.)
- •* Acute or chronic disease at time of TB31F administration, clinically
- •significant pulmonary, cardiovascular, hepatic or renal functional abnormality,
- •as determined by physical examination or laboratory screening tests:
- •o Acute disease is defined as the presence of a moderate or severe illness with
- •or without fever. Subjects with a minor illness on the day of TB31F
- •administration will be temporarily excluded from participation, but may be
- •re-evaluated for inclusion at a later date. Subjects with a positive SARS-CoV2
- •test at inclusion will be (temporarily) excluded from participation but may be
- •re-evaluated for inclusion at a later date (following current Radboudumc
- •guidelines).
- •o Fever * 38.0°C (100.4°F).
- •o Any abnormal and clinically significant baseline laboratory screening tests
- •(appendix 1).
- •* History of malignancy of any organ system (other than localized basal cell
- •carcinoma of the skin), treated or untreated, within the past 5 years.
- •* Chronic use of i) immunosuppressive drugs, ii) antibiotics, iii) or other
- •immune modifying drugs within three months prior to study onset (inhaled and
- •topical corticosteroids and oral anti-histamines exempted) or expected use of
- •such during the study period.
- •* Positive urine toxicology test for cannabis, cocaine or amphetamines at
- •screening or at inclusion.
- •* Screening tests positive for Human Immunodeficiency Virus (HIV), active
- •Hepatitis B Virus (HBV), Hepatitis C Virus (HCV).
- •* Use of any investigational or non-registered product (drug or vaccine) during
- •the study period other than the study product.
- •* Participation in any other clinical study in the 30 days prior to the start
- •of the study or during the study period.
- •* History of adverse reactions to monoclonal antibodies
- •* Prior receipt of an investigational antimalarial monoclonal antibody.
- •* Administration of immunoglobulins and/or any blood products within the three
- •months preceding the first dose of study mAb or planned administration during
- •the study period.
- •* Any history of malaria, positive serology for P. falciparum, or previous
- •participation in any malaria (vaccine) study or CHMI.
- •* Body weight > 115 kg
- •* Being an employee or student of the department of Medical Microbiology or
- •Medium Care of the Radboudumc.
- •* History of drug or alcohol abuse interfering with normal function in the
- •period of one year prior to study onset.
- •* Any other condition or situation that would, in the opinion of the
- •investigator, place the subject at an unacceptable risk of injury or render the
- •subject unable to meet the requirements of the protocol.
研究者
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