ACTRN12622000545763已完成1 期
A phase l, single-blind, placebo-controlled trial designed to assess the safety and tolerability of a single intravenous dose of MTx-COVAB36 in healthy volunteers.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
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 50 Years（—）
- 性别
- All
入选标准
- •1. Healthy male or female participants aged 18 years to 50 years at the time of consent
- •2. Ability to read, understand and provide written informed consent
- •3. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
- •4. Healthy participants as established by medical history, laboratory examination, physical examination, vital signs, and ECG during screening and as per the clinical judgment of the investigator
- •5. Body mass index (BMI) of 18.0 to 32.0 kg/m2 (inclusive)
- •6. For Woman of Childbearing Potential (WOCBP): agrees to practice true abstinence or agrees to use a highly effective method of contraception consistently from 30 days prior to Day 1 until end of the study (Day 63). Highly effective contraception includes hormonal contraception, placement of intrauterine device (IUD) or intrauterine system (IUS), or a vasectomized partner (performed at least 6 months prior to her screening) who has been documented to no longer produce sperm. Verbal confirmation from the participant through medical interview is acceptable. No contraception requirements for participants in exclusive same-sex relationship.
- •7. For male participant: must agree to practice true abstinence or use condom if he has a partner of childbearing potential, or must be surgically sterilized (performed at least 6 months prior and documented to no longer produce sperm. Verbal confirmation through medical interview is acceptable). Participant to practice abstinence (if applicable) or use condom until end of the study (Day 63). No contraception requirements for participants in exclusive same-sex relationship.
- •8. Accessible veins in the forearms for venepuncture and/or intravenous cannulation
排除标准
- •1. Participant with active SARS-CoV-2 infection, verified by RT-PCR test
- •2. Participants tested positive for human immunodeficiency virus (HIV antibody screen), Hepatitis B virus (HBsAg screen) or Hepatitis C virus (HCV antibody screen)
- •3. History of administration of any investigational or non-registered drug within 30 days or 5 half-lives, whichever is longer, prior to administration of study drug, or planned administration during the course of study participation
- •4. History of any reaction to monoclonal antibodies
- •5. History of clinically relevant atopic diseases and/or known allergies to the trial product or its components
- •6. History of any major pulmonary, cardiovascular, renal, neurological (e.g., cerebrovascular events), metabolic, gastrointestinal, hepato-biliary, or hematological functional abnormality, malignancy (except for adequately treated basal cell carcinoma or squamous cell carcinoma of the skin), or mental disability as per discretion of the investigator
- •7. Any clinically significant laboratory findings at screening and enrolment and at Day-1; one retest is allowed at screening and/or at Day-1
- •8. Acute illness (moderate or severe) and/or fever (body temperature greater than or equal to 38 °C) during the 72 hours prior to planned study drug application
- •9. Participants with altered immunocompetence such as participants with ongoing cancer treatment, human immunodeficiency virus infection, organ transplant or any other active immune system disorder
- •10. Receipt of immunoglobulin or blood products within 6 months prior to enrolment
- •11. Receipt of a monoclonal antibody within previous 6 months or 5 half-lives, whichever is longer
- •12. Planned surgery (excluding minor procedures such as tooth extraction or incision and drainage) during the course of the study
- •13. Receipt of any standard vaccine within 14 days prior to Day 1
- •14. History of alcoholism or drug addiction (as per DSM-V) within 1 year prior to screening
- •15. Use of prescription drugs within 7 days prior to Day 1 or for 5 half-lives whichever is longer, or during the study, except for hormonal contraceptives or positive result in urine drug screen or alcohol breath test at screening or Day-1
- •16. Use of over-the-counter medication within 7 days prior to Day 1 or during the study; medication such as paracetamol and ibuprofen may be permitted at the discretion of the investigator and sponsor
- •17. Receipt of immunosuppressive medications within 6 months prior to enrolment, or any active or prior history of immunodeficiency (receipt of any course of systemic corticosteroids for more than
- •a 7-day duration and with a prednisolone equivalent dose of more than 5 mg per day within 6 months prior to enrolment will exclude a participant; inhaled or topical steroids are allowed)
- •18. Pregnant, lactating, or planned pregnancy during the study period
- •19. Inability to comply with the study protocol in the opinion of the investigator
- •20. Participant has any plans to permanently relocate from the area prior to the completion of the study or to leave for an extended period of time when study visits would need to be scheduled
- •21. Concurrent participation in another interventional clinical study investigating a vaccine, drug, medical device, or medical procedure in the 30 days preceding the study drug administration or during the course of the study
- •22. Abnormal vital signs including systolic blood pressure (SBP) less than 90 or greater than 150 mm
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