A Two-Part Single and Multiple Ascending Dose Trial of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LBT-3627 in Healthy Participants and in Participants With Parkinson's Disease.
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 64
- 试验地点
- 4
- 主要终点
- Incidence, nature, and severity of adverse events [Safety and Tolerability]
研究概览
简要总结
Phase I a/b SAD/MAD study to evaluate safety and tolerability of LBT-3627 in both healthy volunteers and Parkinson's patients.
详细描述
Evaluate the safety and tolerability of LBT-3627 in both a single and multiple ascending dose study.
Phase Ia will explore safety and tolerability first in healthy volunteers then followed by Parkinson's patients after a single dose. Dose levels will escalate per cohort.
Phase Ib will explore safety and tolerability in Parkinson's patients after multiple doses. Dose levels will escalate per cohort.
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)
盲法说明
Placebo controlled, double blind (patient and investigator)
入排标准
- 年龄范围
- 30 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Both cohorts (Healthy Volunteers and Parkinson's Disease)
- •Key inclusion criteria
- •Male or female, 30-89 years inclusive at screening
- •BMI 18-32 kg/m²
- •Vital signs, ECG (QTcF <450 ms male / <470 ms female), and safety labs without clinically significant abnormality; no orthostatic hypotension
- •Women of non-childbearing potential, or using highly effective contraception per protocol
排除标准
- •Immunomodulators / steroids - HV: any (incl. OTC) within 90 days; PD: systemic within 60 days and topical/nasal-inhaled OTC within 7 days (both waivable only with Sponsor approval)
- •Vaccine within 60 days (HV) / 45 days (PD) of first dose
- •CoQ10 within 5 days
- •Inadequate renal function (CrCl ≤ 60 mL/min; ≤ 79 if HV under 40), or LFTs / bilirubin > 1.5× ULN
- •Clinically significant cardiovascular, hepatic, renal, neurological, or psychiatric disease
- •Active infection requiring systemic anti-infectives within 14 days; positive HBV/HCV/HIV serology
- •Parkinson's Disease participants - additional key inclusion criteria
- •PD diagnosis by a neurologist/geriatrician, 6 months to < 11 years before first dose, per MDS clinical diagnostic criteria
- •Hoehn & Yahr stage 1-3
- •If on levodopa: stable ≥ 2 months and able to withhold ≥ 12 hours (overnight) around dosing/assessments; if not, remain treatment-naïve through end of study
- •Parkinson's Disease participants - additional key exclusion criteria
- •Prior PD brain surgery, focused ultrasound, or neuromodulation; no anti-amyloid/anti-tau biologics
- •Antibiotics within 30 days; OTC pre/probiotics; ≥ 3 unexplained falls in 12 months
- •Note: Additional protocol-defined criteria apply.
研究组 & 干预措施
Healthy Volunteers - SAD
Single dose of LBT-3627 administered to healthy volunteers
干预措施: Placebo (Drug)
Parkinson's disease patients - SAD
Single dose of LBT-3627 administered to Parkinson's disease patients
干预措施: LBT-3627 (Drug)
Healthy Volunteers - SAD
Single dose of LBT-3627 administered to healthy volunteers
干预措施: LBT-3627 (Drug)
Parkinson's disease patients - MAD
Multiple doses of LBT-3627 administered to Parkinson's disease patients
干预措施: Placebo (Drug)
Parkinson's disease patients - MAD
Multiple doses of LBT-3627 administered to Parkinson's disease patients
干预措施: LBT-3627 (Drug)
Parkinson's disease patients - SAD
Single dose of LBT-3627 administered to Parkinson's disease patients
干预措施: Placebo (Drug)
结局指标
主要结局
Incidence, nature, and severity of adverse events [Safety and Tolerability]
时间窗: Day of treatment to end of follow-up period (1, 2 or 4 weeks)
次要结局
- Maximum Plasma Concentration [Cmax](Day of treatment to end of follow-up period (1, 2 or 4 weeks))
- Elimination half life [T1/2](Day of treatment to end of follow-up period (1, 2 or 4 weeks))
- Concentration [C](Day of treatment to end of follow-up period (1, 2 or 4 weeks))
- Volume of Distribution [Vd](Day of treatment to end of follow-up period (1, 2 or 4 weeks))
- Area under the curve [AUC](Day of treatment to end of follow-up period (1, 2 or 4 weeks))
- Bioavailability [f](Day of treatment to end of follow-up period (1, 2 or 4 weeks))
- Time to reach Cmax [Tmax](Day of treatment to end of follow-up period (1, 2 or 4 weeks))
- Clearance [CL](Day of treatment to end of follow-up period (1, 2 or 4 weeks))