NL-OMON54871已完成不适用
A Phase 1 Study to Evaluate the Safety, Tolerability, and Immunogenicity of UBITh® PD Immunotherapeutic Vaccine (UB-312) in Healthy Participants and Participants with Parkinson*s Disease - Safety, Tolerability, and Immunogenicity of UB-312 in HV and PD patients
nited Neuroscience (Subsidiary of Vaxxinity)0 个研究点目标入组 70 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
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
- •Participants may be included in the clinical trial only if they meet all of the
- •following criteria:
- •1. Written informed consent is signed and dated by the participant
- •2. Male or female aged 40 to 85 years old, inclusive at screening
- •3. Participants must have a body mass index (BMI) between 18 and 32 kg/m2,
- •inclusive at screening, and with a minimum weight of 50 kg
- •4. Expected to be able to undergo all study procedures
- •5. Women must be of non-childbearing potential (postmenopausal for at least 12
- •months prior to screening or surgically sterile documented) or if of
- •child-bearing potential, must be using medically acceptable contraceptive
- •measures throughout the duration of the study and for at least 56 weeks after
- •their last dose of study treatment.
- •6. Male participants and their partners of childbearing potential must commit
- •to the use of medically acceptable contraception for the study duration and for
- •at least 90 days after their last dose of study treatment. Men must refrain
- •from donating sperm during this same period. The female partners should be
- •asked to use a contraception method that is medically acceptable, and these
- •contraceptive measures should be used throughout the duration of the study and
- •for at least 90 days after their last dose of study treatment.
- •For Part B only:
- •7. A diagnosis of PD, confirmed by a neurologist
- •8. Hoehn & Yahr Stage <= III at Screening
- •9. Stable treatment of permitted antiparkinsonian medications from 30 days
- •prior to first study drug administration or 60 days for MAO-B inhibitors, and
- •expected to remain stable throughout the study unless required adjustment or
- •initiation per the investigator*s judgement, except for short-acting rescue
- •medications, which are allowed (see Section 7.1.1 for the list of permitted
- •medications).
- •10. For participants that will need a DaTscan: must be willing and able from a
- •medical standpoint to withhold medication that might interfere with dopamine
- •transporter SPECT imaging (Neuroleptics, metoclopramide, alpha methyldopa,
- •methylphenidate, reserpine, or amphetamine derivative) for at least 5
- •half-lives prior to screening DaTscan imaging
排除标准
- •Participants will be excluded from the clinical trial for any of the following
- •1. Clinically significant abnormalities, as judged by the investigator, in test
- •results (including hepatic and renal panels, complete blood count, chemistry
- •panel, urinalysis and imaging). In the case of uncertain or questionable
- •results, tests performed during screening may be repeated before randomization
- •to confirm eligibility or judged to be clinically irrelevant.
- •2. History of medical, neurological or psychiatric conditions, which in the
- •opinion of the investigator may compromise participant*s safety or scientific
- •value of the study, posing an unacceptable risk to the participant or interfere
- •with the participant's ability to comply with study procedures or abide by
- •study restrictions.
- •3. History of Substance Use Disorder within the past 2 years before screening
- •(Diagnostic and Statistical Manual of Mental Disorders-5 [DSM-V] criteria) or
- •confirmed drugs of abuse or alcohol at Screening. Positive urine drug screen
- •for prescribed medication is allowed at the discretion of the PI.
- •4. Acute or chronic infection with human immunodeficiency virus (HIV),
- •hepatitis C virus (HCV) or hepatitis B virus (HBV) at Screening, or any
- •confirmed or suspected immunosuppressive or immunodeficient condition,
- •including HIV-1, HIV-2 infection, cytotoxic therapy in the previous 5 years.
- •5. History or evidence of an autoimmune disorder (e.g. Sjogren*s syndrome,
- •systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis etc.),
- •which in the opinion of the investigator may compromise patient*s safety or
- •scientific value of the study, posing an unacceptable risk to the participant.
- •6. Level of anti-cyclic citrullinated peptide (anti-CCP) above upper limit of
- •normal at Screening.
- •7. Positive antinuclear antibodies (ANA) except judged to be clinically
- •irrelevant by the investigator.
- •8. History of anergy.
- •9. Any confirmed significant allergic reactions (urticaria or anaphylaxis)
- •against any drug or vaccine, or multiple drug allergies (non-active hay fever
- •is acceptable).
- •10. History of cancer (except basal cell and in situ squamous cell carcinomas
- •of the skin that have been excised and resolved) which has not been in
- •remission for at least 5 years prior to Screening.
- •11. Clinically significant abnormal ECG or blood pressure measurement at
- •screening or before the first dosing, as judged by the Investigator.
- •12. Contraindication to MRI, including but not limited to the presence of metal
- •devices or implants (e.g. pacemaker, vascular- or heart-valves, stents, clips),
- •metal deposited in the body (e.g. bullets or shells), or metal grains in the
- •13. Receipt of an investigational product or device, or participation in a drug
- •research study within a period of 90 days before baseline at V1.
- •14. Participated/participating in any clinical trial with monoclonal antibodies
- •or vaccines directed against aSyn.
- •15. Underwent any procedures/studies involving intracranial surgery,
- •implantation of a device into the brain or stem cell study.
- •16. Pregnancy confirmed by a positive pregnancy test.
- •17. Participants who are currently breastfeeding, intend to breastfeed during
- •the study or are planning to get pregnant and breastfeed within 56 weeks after
- •last injection.
- •18. Use of any prohibited medi
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