A Single Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of 24 Hour and 72 Hour Subcutaneous Infusions of ABBV-951 in Subjects With Parkinson's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 29
- 试验地点
- 7
- 主要终点
- Adverse Events
研究概览
简要总结
The purpose of the study is to assess the safety, tolerability, and pharmacokinetics of single, ascending doses of ABBV-951 administered as a subcutaneous bolus infusion followed by a continuous subcutaneous infusion in subjects with Parkinson's disease.
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
- Single (Participant)
入排标准
- 年龄范围
- 45 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a diagnosis of definite idiopathic PD, which is LD responsive, according to the United Kingdom Parkinson's Disease Society Brain Bank Criteria.
- •Subject must be taking an optimized and stable regimen of oral medications for PD, which has remained stable and unchanged for at least 30 days before dosing in this study. This regimen must include oral carbidopa/levodopa (CD/LD) tablets (e.g., Sinemet).
- •Females must have negative results for pregnancy tests at screening and prior to confinement.
- •If male, subject must be surgically sterile or practicing an adequate method of birth control from initial study drug administration until 30 days after last dose of study drug.
- •Body Mass Index (BMI) is 18.0 to 38.0, inclusive.
- •A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
排除标准
- •Receipt of any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration.
- •History of significant skin conditions or disorders (e.g., psoriasis, atopic dermatitis, etc.) or evidence of recent sunburn, acne, scar tissue, tattoo, open wound, branding, or colorations that in the Investigator's opinion would interfere with the infusion of the study drug or could interfere with study assessments.
- •Use of any medication from the prohibited concomitant therapies.
- •Subjects with glomerular filtration rate (GFR) less than 45 ml/min/1.73 m2 as determined by the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation.
- •Donation or loss of 550 mL or more blood volume (including plasmapheresis) or receipt of a transfusion of any blood product within 8 weeks prior to initial study drug administration.
- •Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive ABBV-951.
研究组 & 干预措施
ABBV-951 Dose 1
Participants will receive dose 1 of ABBV-951.
干预措施: ABBV-951 (Drug)
ABBV-951 Dose 2
Participants will receive dose 2 of ABBV-951.
干预措施: ABBV-951 (Drug)
ABBV-951 Dose 3
Participants will receive dose 3 of ABBV-951.
干预措施: ABBV-951 (Drug)
ABBV-951 Dose 4
Participants will receive dose 4 of ABBV-951.
干预措施: ABBV-951 (Drug)
ABBV-951 Dose 5
Participants will receive dose 5 of ABBV-951.
干预措施: ABBV-951 (Drug)
ABBV-951 Dose 6
Participants will receive dose 6 of ABBV-951.
干预措施: ABBV-951 (Drug)
ABBV-951 Dose 7
Participants will receive dose 7 of ABBV-951.
干预措施: ABBV-951 (Drug)
ABBV-951 Dose 8
Participants will receive dose 8 of ABBV-951.
干预措施: ABBV-951 (Drug)
结局指标
主要结局
Adverse Events
时间窗: 24 hours
Number of participants reporting adverse events
Maximum Observed Plasma Concentration (Cmax) of Levodopa
时间窗: Hour 0-24
Maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.
Time to maximum observed plasma concentration (Tmax) of Levodopa
时间窗: Hour 0-24
Time to maximum observed plasma concentration of levodopa following a single infusion of ABBV-951.
Area Under the Plasma Concentration-Time Curve (AUC) of Levodopa
时间窗: Hour 0-24
Area under the plasma concentration-time curve following a single infusion of ABBV-951.
Terminal phase elimination half-life (T1/2)
时间窗: Up to 72 hours
Terminal phase elimination half-life (t1/2) will be assessed.
Terminal phase elimination rate constant (β)
时间窗: Up to 72 hours
Apparent terminal phase elimination rate constant (β or Beta)
次要结局
- Corrected QT (QTc) Interval(Up to 76 hours)