A First-in-Human, Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-859 After Single Ascending Doses in Healthy Adult Subjects
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 pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-859 after single ascending doses in healthy adult volunteers.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
- •Body Mass Index (BMI) is >= 18.0 to <= 32 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 Electrocardiogram (ECG).
排除标准
- •History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, endocrine, immunological, pulmonary, metabolic, neurological or psychiatric disease or disorder, or any uncontrolled medical illness.
- •History of any clinically significant sensitivity or allergy to any medication or food.
- •History of or active medical condition(s) or surgical procedure(s) that might affect gastrointestinal motility, pH, or absorption [e.g., Crohn's disease, celiac disease, gastroparesis, short bowel syndrome, gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), cholecystectomy, vagotomy, bowel resection, etc.].
- •Evidence of dysplasia or history of malignancy (including lymphoma and leukemia) other than successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix.
- •History or evidence of active Tuberculosis disease or latent Tuberculosis infection.
研究组 & 干预措施
Group 1
Participants will receive either ABBV-859 single Dose A, or the Placebo equivalent, on Study Day 1
干预措施: ABBV-859 (Drug)
Group 8
Participants will receive either ABBV-859 single Dose H, or the Placebo equivalent, on Study Day 1
干预措施: ABBV-859 (Drug)
Group 8
Participants will receive either ABBV-859 single Dose H, or the Placebo equivalent, on Study Day 1
干预措施: Placebo for ABBV-859 (Drug)
Group 1
Participants will receive either ABBV-859 single Dose A, or the Placebo equivalent, on Study Day 1
干预措施: Placebo for ABBV-859 (Drug)
Group 2
Participants will receive either ABBV-859 single Dose B, or the Placebo equivalent, on Study Day 1
干预措施: ABBV-859 (Drug)
Group 2
Participants will receive either ABBV-859 single Dose B, or the Placebo equivalent, on Study Day 1
干预措施: Placebo for ABBV-859 (Drug)
Group 3
Participants will receive either ABBV-859 single Dose C, or the Placebo equivalent, on Study Day 1
干预措施: ABBV-859 (Drug)
Group 3
Participants will receive either ABBV-859 single Dose C, or the Placebo equivalent, on Study Day 1
干预措施: Placebo for ABBV-859 (Drug)
Group 4
Participants will receive either ABBV-859 single Dose D, or the Placebo equivalent, on Study Day 1
干预措施: ABBV-859 (Drug)
Group 4
Participants will receive either ABBV-859 single Dose D, or the Placebo equivalent, on Study Day 1
干预措施: Placebo for ABBV-859 (Drug)
Group 5
Participants will receive either ABBV-859 single Dose E, or the Placebo equivalent, on Study Day 1
干预措施: ABBV-859 (Drug)
Group 5
Participants will receive either ABBV-859 single Dose E, or the Placebo equivalent, on Study Day 1
干预措施: Placebo for ABBV-859 (Drug)
Group 6
Participants will receive either ABBV-859 single Dose F, or the Placebo equivalent, on Study Day 1
干预措施: ABBV-859 (Drug)
Group 6
Participants will receive either ABBV-859 single Dose F, or the Placebo equivalent, on Study Day 1
干预措施: Placebo for ABBV-859 (Drug)
Group 7
Participants will receive either ABBV-859 single Dose G, or the Placebo equivalent, on Study Day 1
干预措施: ABBV-859 (Drug)
Group 7
Participants will receive either ABBV-859 single Dose G, or the Placebo equivalent, on Study Day 1
干预措施: Placebo for ABBV-859 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to 99 Days
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not the event is considered causally related to the use of the product.
Maximum Observed Serum Concentration (Cmax) of ABBV-859
时间窗: Up to 99 Days
Cmax of ABBV-859
Time to Cmax (Tmax) of ABBV-859
时间窗: Up to 99 Days
Time to Cmax (Tmax) of ABBV-859
Terminal Phase Elimination Rate Constant (Beta) of ABBV-859
时间窗: Up to 99 Days
Beta of ABBV-859
Terminal Phase Elimination Half-Life (t1/2) of ABBV-859
时间窗: Up to 99 Days
t1/2 of ABBV-859
Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time of the Last Measurable Concentration (AUCt) of ABBV-859
时间窗: Up to 99 Days
AUCt of ABBV-859
AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-859
时间窗: Up to 99 Days
AUCinf of ABBV-859
Apparent Clearance (CL/F) ABBV-859
时间窗: Up to 99 Days
CL/F of ABBV-859
Antidrug Antibody (ADA)
时间窗: Up to 99 Days
Incidence and concentration of anti-drug antibodies.
次要结局
未报告次要终点