A First in Human, Single Ascending Dose Study for the Assessment of Pharmacokinetics, Safety and Tolerability of ABBV-990 in Healthy Male and Female Subjects
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990
研究概览
简要总结
This study will assess how safe ABBV-990 is and how ABBV-990 moves through the body of adult healthy participants. Adverse Events will be assessed.
ABBV-990 is an investigational drug being developed for the treatment of SARS-CoV-2 infections. Participants are randomly assigned to one of the 5 treatment groups. Each group receives different treatment. There is 1 in 4 chance that participants are assigned to placebo. Approximately 40 adult healthy volunteers will be enrolled in a single site in the United States.
Participants will receive oral tablet of ABBV-990 or matching placebo on Day 1 and followed for approximately 30 days.
Participants will be confined for 5 days. Adverse Events and blood tests will be performed.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body Mass Index (BMI) is >= 18.0 to <= 32.0 kg/m
- •Laboratory values meet the protocol-specified criteria.
- •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).
- •In the opinion of the investigator, participant is a suitable candidate for enrollment in the study.
排除标准
- •Have any clinically significant ECG abnormalities.
- •History of any clinically significant sensitivity or allergy to any medication or food.
- •Known active SARS-CoV-2 infection at screening and upon initial confinement.
- •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 drug.
- •Currently enrolled in another interventional clinical study.
研究组 & 干预措施
Group 1
Participants will receive ABBV-990 Dose A or matching placebo.
干预措施: ABBV-990 (Drug)
Group 1
Participants will receive ABBV-990 Dose A or matching placebo.
干预措施: Placebo for ABBV-990 (Drug)
Group 2
Participants will receive ABBV-990 Dose B or matching placebo.
干预措施: ABBV-990 (Drug)
Group 2
Participants will receive ABBV-990 Dose B or matching placebo.
干预措施: Placebo for ABBV-990 (Drug)
Group 3
Participants will receive ABBV-990 Dose C or matching placebo.
干预措施: ABBV-990 (Drug)
Group 3
Participants will receive ABBV-990 Dose C or matching placebo.
干预措施: Placebo for ABBV-990 (Drug)
Group 4
Participants will receive ABBV-990 Dose D or matching placebo.
干预措施: ABBV-990 (Drug)
Group 4
Participants will receive ABBV-990 Dose D or matching placebo.
干预措施: Placebo for ABBV-990 (Drug)
Group 5
Participants will receive ABBV-990 Dose E or matching placebo.
干预措施: ABBV-990 (Drug)
Group 5
Participants will receive ABBV-990 Dose E or matching placebo.
干预措施: Placebo for ABBV-990 (Drug)
结局指标
主要结局
AUC From Time 0 to Infinite Time (AUCinf) of ABBV-990
时间窗: Up to approximately 5 days
AUCinf of ABBV-990.
Number of Participants Experiencing Adverse Events (AEs)
时间窗: Up to approximately 30 days
An adverse event (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. The investigator assesses the relationship of each event to the use of study.
Maximum Observed Plasma Concentration (Cmax) of ABBV-990
时间窗: Up to approximately 5 days
Cmax of ABBV-990.
Time to Cmax (Tmax) of ABBV-990
时间窗: Up to approximately 5 days
Tmax of ABBV-990.
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-990
时间窗: Up to approximately 5 days
Apparent terminal phase elimination rate constant of ABBV-990.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-990
时间窗: Up to approximately 5 days
Terminal phase elimination half-life of ABBV-990.
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-990
时间窗: Up to approximately 5 days
AUCt of ABBV-990.
次要结局
未报告次要终点