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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Frequency of Adverse Events
研究概览
简要总结
This is a 44-week, randomized, placebo-controlled, double-blind, single-center, phase 1 clinical trial consisting of a dose-escalation Part A study in healthy participants, followed by a Part B in participants with Parkinson's disease with a selected doses from Part A.
详细描述
This is a first-in-human Phase 1 study to determine the safety, tolerability, and immunogenicity of UB-312 in healthy participants and in participants with Parkinson's disease (PD). UB-312 is a UBITh®-enhanced synthetic peptide-based vaccine and may provide an active immunotherapy option for treating synucleinopathies including the most prevalent form, PD.
The study consists of two parts. Part A of the study with healthy participants will consist of dose escalation and cohort staggering for up to seven planned dose levels or placebo. Part B of the study will consist of two cohorts of participants with Parkinson's disease (PD). Dosing for Part B will be based on safety, tolerability and immunogenicity from Part A. All eligible participants will be enrolled in a 44-week study consisting of 20 weeks of treatment and 24 weeks of follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female aged 40 to 85 years old, inclusive at screening
- •Expected to be able to undergo all study procedures
- •Other inclusion criteria apply
- •For Part B only:
- •A diagnosis of PD, confirmed by a neurologist
- •Hoehn &Yahr Stage ≤ III at Screening
- •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
排除标准
- •Clinically significant abnormalities, as judged by the investigator
- •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
- •Acute or chronic infection as judged by the investigator, for positive human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis B virus (HBV)
- •History or evidence of an autoimmune disorder
- •History of anergy.
- •Participated/participating in any clinical trial with monoclonal antibodies or vaccines directed at aSyn
- •Other exclusion criteria apply
- •For Part B only:
- •Other known or suspected cause of Parkinsonism other than idiopathic PD
- •History or evidence at Screening of PD-related freezing episodes, falls, or orthostatic hypotension
- •Dopamine transporter single-photon emission computerized tomography scan (DaTscan) inconsistent with dopamine transporter deficit.
- •Clinically significant neurological disease other than PD
研究组 & 干预措施
Part B: UB-312 300/100 mcg
UB-312 300 mcg at Week 1 and 100 mcg at Weeks 5 and 13 by intramuscular injection
干预措施: UB-312 (Biological)
Part A: UB-312 40 mcg
UB-312 40 mcg by intramuscular injection at Weeks 1, 5 and 13
干预措施: UB-312 (Biological)
Part A: UB-312 100 mcg
UB-312 100 mcg by intramuscular injection at Weeks 1, 5 and 13
干预措施: UB-312 (Biological)
Part A: UB-312 40/300 mcg
UB-312 40 mcg at Week 1 and 300 mcg at Weeks 5 and 13 by intramuscular injection
干预措施: UB-312 (Biological)
Part A: UB-312 300 mcg
UB-312 300 mcg by intramuscular injection at Weeks 1, 5 and 13
干预措施: UB-312 (Biological)
Part A: UB-312 40/1000 mcg
UB-312 40 mcg at Week 1 and 1000 mcg at Weeks 5 and 13 by intramuscular injection
干预措施: UB-312 (Biological)
Part A: UB-312 1000 mcg
UB-312 1000 mcg by intramuscular injection at Weeks 1, 5 and 13
干预措施: UB-312 (Biological)
Part A: UB-312 2000 mcg
UB-312 2000 mcg by intramuscular injection at Weeks 1, 5 and 13
干预措施: UB-312 (Biological)
Part A: Placebo
Placebo by intramuscular injection at Weeks 1, 5 and 13
干预措施: Placebo (Biological)
Part B: UB-312 300 mcg
UB-312 300 mcg at Weeks 1, 5 and 13 by intramuscular injection
干预措施: UB-312 (Biological)
Part B: Placebo
Placebo by intramuscular injection at Weeks 1, 5 and 13
干预措施: Placebo (Biological)
结局指标
主要结局
Frequency of Adverse Events
时间窗: 44 weeks
Number of AEs will be assessed
Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in Blood
时间窗: 44 weeks
Number of Participants with Anti-aSyn Antibodies in Blood from Weeks 1 through 45.
Immunogenicity of UB-312 as Determined by Anti-aSyn Antibodies in CSF
时间窗: 44 weeks
Number of Participants with Anti-aSyn Antibodies in CSF from Weeks 1 through 45.
次要结局
未报告次要终点