NCT07840027招募中1 期
A Randomized, Placebo-controlled, Double-blind, Dose-finding Phase 1b Study to Assess the Safety, Immunogenicity and Pharmacodynamics of TRB-001 in Early Idiopathic Parkinson's Disease Patients
Tridem Bioscience FlexCo1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年9月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- To investigate treatment-emergent adverse events at 2 different dose levels (LD, HD) compared to placebo in PD patients over 6 months (safety and tolerability of TRB-001)
研究概览
简要总结
This is a randomized, placebo-controlled, double-blind, dose-finding phase 1b study with the purpose to assess the safety, immunogenicity and pharmacodynamics of TRB-001 in early idiopathic Parkinson's Disease patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female or male patients aged 40-75 years old. Refer to section 5.3 for reproductive criteria for male and female participants
- •Diagnosed with idiopathic PD within the previous 4 years based on the MDS-PD criteria. The diagnosis must be confirmed by bradykinesia plus one of the other cardinal signs (resting tremor, rigidity or postural instability not caused by primary visual, vestibular, cerebellar, or proprioceptive dysfunction) being present
- •Severity ≤2 in the modified Hoehn and Yahr scale
- •Brain magnetic resonance imaging (MRI) results should be consistent with the diagnosis of PD
- •If on symptomatic PD medications (L-DOPA (+/- benserazide, carbidopa), COMT inhibitors (entacapone, opicapone), dopamine agonists (pramipexol, ropinirole, rotigotine, apomorphine), MAO-B inhibitors (safinamid, selegiline, rasagiline) or NMDA receptor antagonists (amantadine)), doses must be stable for at least 3 months before study entry
- •Understands and agrees to comply with the study procedures and provides written informed consent
排除标准
- •Known or suspected allergy, or history of anaphylaxis, to vaccines or their excipients, or kanamycin, if considered relevant by the investigator
- •Presence or history of autoimmune disease or immunodeficiency, if considered relevant by the investigator
- •Presence of active infectious disease (hepatitis B, hepatitis C, or human immunodeficiency virus (HIV))
- •Significant cognitive impairment or clinical dementia, or a Montreal Cognitive Assessment (MoCA) score <26
- •High suspicion of other parkinsonian syndromes, such as multiple system atrophy, progressive supranuclear palsy, drug induced Parkinsonism and post-encephalitic Parkinsonism
- •Any relevant systemic illness. This includes cardiovascular, hepatic, gastroenterological, respiratory, endocrinological, hematologic disease, or any other condition that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study, unless patient has been on stable doses of medication for any of these concurrent illnesses for at least 3 months prior to study entry
- •Unstable psychiatric illness, including psychosis, suicidal ideation, untreated major depression, schizophrenia, or bipolar affective disorder within 90 days before Visit 1, as determined by the investigator
- •History of drug or alcohol abuse within the past 5 years
- •Recent history (≤2 years) of cancer (exceptions: basal cell carcinoma, intraepithelial cervical neoplasia)
- •Contraindication for MRI or lumbar puncture
- •Female patients who are pregnant or lactating
- •Birthmarks, tattoos, wounds, or skin conditions that may obscure the assessment of injection site reactions
- •Participation in the active treatment phase of any non-PD clinical trial within 30 days prior to Visit 1
- •Prior treatment with experimental immunotherapeutics for PD, immunosuppressive drugs or treatment with deep brain stimulation. Patient has received or plans to receive any vaccine other than study intervention within 28 days before or 28 days after each study vaccination.
- •Employee at the study site, spouse/partner or relative of any study staff (e.g., investigator, sub-investigators, or study nurse) or relationship to the sponsor
研究组 & 干预措施
low dose (LD)
Experimental
20 µg; 0.1 ml
干预措施: TRB-001 (Biological)
low dose (LD)
Experimental
20 µg; 0.1 ml
干预措施: Placebo (Other)
high dose (HD)
Experimental
100 µg; 0.5 ml
干预措施: TRB-001 (Biological)
high dose (HD)
Experimental
100 µg; 0.5 ml
干预措施: Placebo (Other)
logarithmic dosing (LogD)
Experimental
20, 40, and 100 µg; 0.1, 0.2, and 0.5 ml
干预措施: TRB-001 (Biological)
logarithmic dosing (LogD)
Experimental
20, 40, and 100 µg; 0.1, 0.2, and 0.5 ml
干预措施: Placebo (Other)
结局指标
主要结局
To investigate treatment-emergent adverse events at 2 different dose levels (LD, HD) compared to placebo in PD patients over 6 months (safety and tolerability of TRB-001)
时间窗: 6 months
Incidence of local and systemic treatment-emergent adverse events (TEAEs) (occurrence, intensity, duration, and relationship to IMPs) at LD and HD over 6 months (V1-V6) compared to placebo
To assess immunogenicity of TRB-001 at 2 different dose levels (LD, HD) in PD patients over 6 months
时间窗: 6 months
Titers of anti-α-synuclein antibodies (immunizing peptide, α synuclein monomer) in blood samples at LD and HD over 6 months (V1-V6) compared to placebo as assessed by ELISA
次要结局
- To investigate incidence of Treatment-Emergent Adverse Events compared to placebo in PD patients (Safety and Tolerability of TRB-001)(6 months 18 months)
- To assess immunogenicity of TRB-001 in PD patients(6 months)
- To obtain liquid surrogate biomarkers of PD and evaluate their correlation with clinical activity(6 months 18 months)
- To assess the efficacy of TRB-001 in delaying motor and non motor symptom progression compared to placebo in PD patients using MDS-UPDRS II (activity of daily life) and MDS-UPDRS III (motor-examination) over 18 months(18 months)
研究者
研究点 (1)
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