A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses and Multiple Doses of ABBV-313
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
- 2
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of single and multiple doses of ABBV-313 in healthy adult participants.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 基础科学
- 盲法
- 四盲 (受试者、医护人员、研究者、结局评估者)
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
- BMI is >= 18.0 to <= 29.9 kg/m2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
排除标准
- History of any clinically significant sensitivity or allergy to any medication or food.
- History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.
- Participant has prior exposure to ABBV-313 within the past 300 days.
研究组 & 干预措施
Part 1, Group 1: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
干预措施: Placebo (Drug)
Part 1, Group 2: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
干预措施: ABBV-313 (Drug)
Part 1, Group 2: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
干预措施: Placebo (Drug)
Part 1, Group 3: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
干预措施: ABBV-313 (Drug)
Part 1, Group 3: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
干预措施: Placebo (Drug)
Part 1, Group 4: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
干预措施: ABBV-313 (Drug)
Part 1, Group 4: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
干预措施: Placebo (Drug)
Part 1, Group 5: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
干预措施: ABBV-313 (Drug)
Part 1, Group 6: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
干预措施: ABBV-313 (Drug)
Part 1, Group 6: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
干预措施: Placebo (Drug)
Part 2, Group 7: ABBV-313 or Placebo
Participants will receive multiple doses of ABBV-313 or Placebo
干预措施: ABBV-313 (Drug)
Part 2, Group 7: ABBV-313 or Placebo
Participants will receive multiple doses of ABBV-313 or Placebo
干预措施: Placebo (Drug)
Part 2, Group 8: ABBV-313 or Placebo
Participants will receive multiple doses of ABBV-313 or Placebo
干预措施: ABBV-313 (Drug)
Part 1, Group 5: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
干预措施: Placebo (Drug)
Part 1, Group 1: ABBV-313 or Placebo
Participants will receive a single dose of ABBV-313 or Placebo
干预措施: ABBV-313 (Drug)
Part 2, Group 8: ABBV-313 or Placebo
Participants will receive multiple doses of ABBV-313 or Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to Approximately Day 329
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Maximum Observed Plasma Concentration (Cmax) of ABBV-313
时间窗: Up to Approximately Day 329
Cmax of ABBV-313.
Time to Cmax (Tmax) of ABBV-313
时间窗: Up to Approximately Day 329
Tmax of ABBV-313.
Terminal Phase Elimination Rate Constant (Beta) of ABBV-313
时间窗: Up to Approximately Day 329
Beta of ABBV-313.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-313
时间窗: Up to Approximately Day 329
t1/2 of ABBV-313.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-313
时间窗: Up to Approximately Day 329
AUCt of ABBV-313.
次要结局
未报告次要终点
研究者
研究点 (2)
标识符
- NCT 编号
- NCT07673120
- 其他研究编号
- M26-216
日期
- 首次提交
- (3个月前)
- 首次发布
- (3个月前)
- 主要完成日期
- (明年)
- 研究完成日期
- (明年)
- 最近核实
- (29天前)
- 最近更新
- (前天)
监管与共享
- FDA 监管药物
- 是
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否