FC-12738 Single Ascending Dose in Health Adult and Patients With ALS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Characterize the safety/tolerability of single-ascending-dose study of FC-12738 in healthy adult participants
研究概览
简要总结
A Phase I, Randomized, Double-Blind, Placebo-Controlled, First-in-human, Single-Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of retro enversio (RT) thymopentin in Healthy Adult Participants and Patients with Amyotrophic Lateral Sclerosis (ALS)
详细描述
This is a first-in-human, randomized, double-blind, placebo-controlled, single-ascending-dose (SAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of retro enversio thymopentin (FC-12738) in healthy adult participants and patients with ALS. The clinical trial will be conducted in two parts, initially a SAD study in 3-sequential cohorts of healthy adult participants (PartA), and then follows another SAD study in 4-6-sequential cohorts of patients with ALS (Part B). Dose escalation in the SAD cohorts will be determined after having reviewed of the interim safety data as well as all available PK and/or PD data from the preceding dose level(s).
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
Each dose cohort will enroll 8 healthy adults participants, participants will be randomly assigned to receive a single subcutaneous (SC) injection of FC-12738 or placebo in a ratio of 6:2, respectively.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
SAD study in Healthy adult participants
A total of 24 healthy adult participants will be enrolled, and then sequentially allocate to 3 planned dose cohorts (A1-A3): 4 mg, 8 mg and 16 mg, respectively.
干预措施: FC-12738 (Drug)
Placebo
Placebo
干预措施: Saline (Drug)
结局指标
主要结局
Characterize the safety/tolerability of single-ascending-dose study of FC-12738 in healthy adult participants
时间窗: 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
AEs (Adverse Events), AEs of special interest (AESI), treatment-emergent AE (TEAE) and serious adverse events(SAE);Serious Adverse Event(s) AE's will be identified from the time of signed ICF (consent form), throughout the entire study until completion of the follow-up visit.
Heart rate measure
时间窗: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
Heart rate will be measured by counting beats per minute
Measure blood pressure with a blood pressue cuff
时间窗: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
blood pressure (BP) systolic and diastolic will be measured in millimeters of mercury (mmHg)
Physical exam signs by counting respiratory rate
时间窗: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
respiratory rate (RR) will be measured in breaths per minute
Physical exam by temperature taken by a thermometer
时间窗: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
The temperature will be measured in degrees centegrade or Fahrenheit 12-lead ECGs parameters; Laboratory data (including fasting serum biochemistry, hematology, coagulation, and urinalysis); Assessment of injection site reactions; and Neurological examination；
Physical exam by 12 lead electrocardiogram
时间窗: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
12-lead ECGs parameters will measure amplitude of the electrical wave in milimeters
Laboratory data will be measured by blood analysis
时间窗: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
Levels of red blood cells will be measured by in number per microliter and white blood cells will be provided as a percent of total white count measured in number per microlliter.
Laboratory data will be measured by serum biochemistry and urinalysis
时间窗: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
Serum biochemistry values and urine components will be measured in miligrams per deciliter
Injection site reactions in normal participants
时间窗: at screening, Day-1, pre-dose and 0.5 hour, 1 hour, 2 hour, 4 hour, 8 hour, 24 hour, 48 hour, post-dose and follow-up visit on Day 8.
Assessment of injection site reactions will be by observation (color) and palpation for soreness or thickening.
次要结局
- Determine the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of single-ascending-dose study of FC-12738 in healthy adult participants(48 hours)
- To determine the pharmacokinetic (PK) profiles in urine of single-ascending-dose study of FC-12738 in healthy adult participants(48 hours)