A Phase 1, Double-blind, Placebo-controlled, First-in-human Trial to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single Ascending Doses of ABBV-1042 in Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Number of Participants Experiencing Adverse Events
研究概览
简要总结
This study will assess the adverse events, tolerability, and how oral ascending doses of ABBV-1042 moves through the body of healthy adult participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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 ≤ 32.0 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.
- •Body weight ˃ 45 kg at the time of screening and upon initial confinement.
- •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 suicidal ideation within one year prior to study treatment administration and/or history of suicidal behavior or non-suicidal self-injury within two years prior to study treatment administration as evidenced by any "yes" answer to questions on the Columbia-Suicide Severity Rating Scale (C-SSRS) at the screening visit or upon initial confinement.
- •Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus, thyroid disorders), malignancy, hematological, immunological, neurological, or psychiatric disease that, , in the opinion of the investigator, could compromise either participant safety or the results of the trial.
研究组 & 干预措施
ABBV-1042 or Placebo-Group 4
Participants will receive an oral dose of ABBV-1042 or placebo on day 1.
干预措施: Placebo (Drug)
ABBV-1042 or Placebo-Group 5
Participants will receive an oral dose of ABBV-1042 or placebo on day 1.
干预措施: ABBV-1042 (Drug)
ABBV-1042 or Placebo-Group 3
Participants will receive an oral dose of ABBV-1042 or placebo on day 1.
干预措施: ABBV-1042 (Drug)
ABBV-1042 or Placebo-Group 3
Participants will receive an oral dose of ABBV-1042 or placebo on day 1.
干预措施: Placebo (Drug)
ABBV-1042 or Placebo-Group 4
Participants will receive an oral dose of ABBV-1042 or placebo on day 1.
干预措施: ABBV-1042 (Drug)
ABBV-1042 or Placebo-Group 1
Participants will receive an oral dose of ABBV-1042 or placebo on day 1.
干预措施: ABBV-1042 (Drug)
ABBV-1042 or Placebo-Group 1
Participants will receive an oral dose of ABBV-1042 or placebo on day 1.
干预措施: Placebo (Drug)
ABBV-1042 or Placebo-Group 2
Participants will receive an oral dose of ABBV-1042 or placebo on day 1.
干预措施: ABBV-1042 (Drug)
ABBV-1042 or Placebo-Group 2
Participants will receive an oral dose of ABBV-1042 or placebo on day 1.
干预措施: Placebo (Drug)
ABBV-1042 or Placebo-Group 5
Participants will receive an oral dose of ABBV-1042 or placebo on day 1.
干预措施: Placebo (Drug)
ABBV-1042 or Placebo-Group 6
Participants will receive an oral dose of ABBV-1042 or placebo on day 1.
干预措施: ABBV-1042 (Drug)
ABBV-1042 or Placebo-Group 6
Participants will receive an oral dose of ABBV-1042 or placebo on day 1.
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants Experiencing Adverse Events
时间窗: Up to approximately 32 days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Maximum Plasma Concentration (Cmax) of ABBV-1042
时间窗: Up to approximately 3 days
Cmax of ABBV-1042
Number of Participants with Abnormal Change From Baseline in Vital Sign Measurements
时间窗: Up to approximately 3 days
Number of participants with abnormal change from baseline in vital sign measurements like systolic and diastolic blood pressure will be assessed.
Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS)
时间窗: Up to approximately 3 days
The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior, with a higher score denoting more severe suicidal ideation and behavior.
Number of Participants with Change from Baseline in Electrocardiogram (ECG)
时间窗: Up to approximately 3 days
12-lead resting ECG will be recorded.
Number of Participants with Abnormal Change in Physical Examinations
时间窗: Up to approximately 3 days
Number of participants with abnormal change in physical examinations in areas like cardiovascular, respiratory, and neurological systems will be assessed.
Number of Participants with Abnormal Change in Clinical Laboratory Test Results Like Hematology will be Assessed
时间窗: Up to approximately 3 days
Number of participants with abnormal change in clinical laboratory test results like hematology will be assessed.
Time to Cmax (Tmax) of ABBV-1042
时间窗: Up to approximately 3 days
Tmax of ABBV-1042
Apparent terminal phase elimination constant (β) of ABBV-1042
时间窗: Up to approximately 3 days
β of ABBV-1042
Terminal Phase Elimination Half-Life (t1/2) of ABBV-1042
时间窗: Up to approximately 3 days
t1/2 of ABBV-1042
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCt) of ABBV-1042
时间窗: Up to approximately 3 days
AUCt of ABBV-1042
Area under the plasma concentration-time curve from time 0 to infinity (AUCinf) of ABBV-1042
时间窗: Up to approximately 3 days
AUCinf of ABBV-1042
次要结局
未报告次要终点