NCT06773962招募中2 期
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of TB006 in Participants With Parkinson's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 62
- 试验地点
- 14
- 主要终点
- Change from Baseline in Parkinson's Disease Rating Scale Score
研究概览
简要总结
The primary objectives of this study are to assess the efficacy of TB006 in improving motor function and to assess the safety of TB006 in participants with Parkinson's Disease (PD).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants voluntarily agree to participate in this study and sign an Institutional Review Board (IRB)-approved informed consent form (ICF) prior to performing any of the screening procedures.
- •Parkinson's Disease Related Criteria:
- •Diagnosis of Parkinson's disease (PD) with motor symptom improvement from levodopa, if applicable.
- •Less than 5 years from the initial PD diagnosis, at the time of ICF.
- •Early-stage PD, with mild symptoms based on standard clinical staging in OFF state.
- •Participants who are on immediate-release levodopa-carbidopa/benserazide.
- •Other Health Related Criteria
- •No active cancer, unless in remission for ≥10 years without ongoing treatment, except fully removed basal cell carcinoma.
- •Free of significant health issues that might interfere with study participation.
- •Other Criteria/Social Circumstances
- •Negative screening for illegal drugs (excluding cannabis), with willingness to abstain during the study and avoid cannabis or alcohol effects during visits.
排除标准
- •Parkinsons's Disease Related Criteria
- •History of sudden, unexpected PD medication OFF episodes.
- •Severe motor complications or disabling symptoms that may impact study involvement.
- •Other Health Related Criteria
- •Any condition or health concern deemed a safety risk or likely to interfere with study results.
- •Severe psychiatric disorders, including psychosis or substance addiction.
- •Allergies or sensitivities to specific study-related treatments or substances.
- •Any prior history of a severe infusion reaction.
- •Other Criteria/Social Circumstances
- •Pregnancy, breastfeeding, or plans for pregnancy or ova donation during or shortly after the study.
- •Recent use of investigational drugs or therapeutic antibodies.
研究组 & 干预措施
TB006
Experimental
Participants will receive TB006 via intravenous (IV) infusion.
干预措施: TB006 (Drug)
Placebo
Placebo Comparator
Participants will receive placebo via IV infusion.
干预措施: Placebo (Drug)
结局指标
主要结局
Change from Baseline in Parkinson's Disease Rating Scale Score
时间窗: Baseline to 28 weeks
Number of Participants Experiencing Adverse Events
时间窗: 28 weeks
Number of Participants Experiencing Serious Adverse Events
时间窗: 28 weeks
次要结局
- Change from Baseline in Parkinson's Disease Rating Scale Sub-score(Baseline to 28 weeks)
- Change from Baseline in Patient Perceived Severity of Disease(Baseline to 28 weeks)
- Change from Baseline in Clinician Perceived Severity of Disease(Baseline to 28 weeks)
研究者
研究点 (14)
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