A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Phase 1 Study to Determine the Safety, Tolerability, and Pharmacokinetics of ALD1910, a Humanized Anti-Pituitary Adenylate Cyclase Activating Peptide (PACAP) Monoclonal Antibody
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Number of participants with treatment-emergent adverse events
研究概览
简要总结
The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALD1910, a monoclonal antibody, administered by intravenous infusion and subcutaneous injection.
详细描述
This is a first-in-humam, randomized, double-blind, placebo-controlled study in a healthy population. Up to 7 single ascending doses (cohorts 1 to 7) will be studied to determine the safety and tolerability of ALD1910. Approximately 96 healthy male and female participants are planned for the study, 64 for Part A and 32 for Part B.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy male or female
- •All female subjects must have a negative pregnancy test result and subjects to use of adequate contraception for the duration of the study.
- •Body Mass Index (BMI) between 18.0 and 30.0 kg/m2, and a total body weight of 50 to 100 kg inclusive.
排除标准
- •Use of prescription meds, nutritional supplements, OTC medications.
- •New or unusually strenuous exercise for the duration of the trial.
- •Current or previous drug or alcohol abuse.
- •Current, or previous smoker within 12 weeks prior to screening. Causal or social smokers are allowed.
- •Previous treatment or clinical trial with a monoclonal antibody 6 months prior to screening.
- •Current participation in any clinical research study.
- •ECG QTcF greater than or equal to 450 msec.
- •Greater than 6.4% glycosylated hemoglobin (HgbA1c) at screening
- •Fasting blood glucose greater than or equal to 126 mg/dL (7 mmol/L) at screening
研究组 & 干预措施
Part B Cohort 10
ALD1910/Placebo; Single dose subcutaneous injection on Day 1
干预措施: ALD1910 (Biological)
Part B Cohort 9
ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1
干预措施: Sumatriptan (Biological)
Part B Cohort 9
ALD1910/Placebo+Sumatriptan; Single Dose IV infusion on Day 1
干预措施: ALD1910 (Biological)
Part A Cohort 1-8
ALD1910/Placebo; Single Dose IV infusion on Day 1
干预措施: ALD1910 (Biological)
结局指标
主要结局
Number of participants with treatment-emergent adverse events
时间窗: From dosing to week 20
Safety and tolerability based on the safety assessments (clinical safety laboratory tests, vital signs, ECG parameters)
次要结局
- Area under the serum concentration-time curve (AUC(0-T))(From dosing to week 20)
- Peak serum concentration (Cmax)(From dosing to week 20)
- Clearance (Cl)(From dosing to week 20)
- Immunogenicity(From dosing to week 20)