A Randomized, Double-Blind, Placebo-Controlled, Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of ABBV-553 in Healthy Volunteers and in Subjects With Psoriasis and Efficacy of ABBV-553 in Subjects With Psoriasis
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- 入组人数
- 12
- 试验地点
- 4
- 主要终点
- Substudy 1: Maximum observed plasma concentration (Cmax) of ABBV-553
研究概览
简要总结
This is a study to assess the pharmacokinetics, safety and tolerability of multiple ascending oral doses of ABBV-553 in healthy volunteers and the pharmacokinetics, safety, tolerability and efficacy of multiple ascending oral doses of ABBV-553 in participants with psoriasis under non-fasting conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female and between 18 and 55 years of age, inclusive, for Substudy 1, OR between 18 and 75 years of age, inclusive, for Substudy
- •If female, participant must be of non-child bearing potential defined as either:
- •a. Postmenopausal: Age > 55 years with no menses for 12 or more months without an alternative medical cause. Postmenopausal: Age <= 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle stimulating hormone (FSH) level >= 40 IU/L (OR) b. Permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
- •Non-postmenopausal females must have a negative urine pregnancy test result at Screening, and a negative serum pregnancy test result on Day -2 or Day -
- •Male participants who are sexually active with women of child bearing potential (WOCBP), even if the male participant has undergone a successful vasectomy, must agree to use condoms from Day 1 through at least 30 days after the last dose of study drug, and male participant agrees not to donate sperm at least 30 days after the last dose of study drug.
- •Body Mass Index (BMI) >= 18.0 to <= 29.9 kg/m2 after rounding to the tenths decimal for Substudy 1 OR BMI >= 18.0 to <= 34.9 kg/m2 after rounding to the tenths decimal for Substudy
- •BMI is calculated as weight measured in kilograms (kg) divided by the square of height measured in meters (m).
- •In the opinion of the Investigator, that the participant is in 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).
- •Must voluntarily sign and date each informed consent form, approved by an Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures and be willing to comply with the requirements of this study protocol.
- •Additional criteria for Substudy 2:
- •Has a clinical diagnosis of chronic plaque psoriasis (with a disease duration of at least 6 months).
- •Has a Psoriasis Area and Severity Index (PASI) score ≥
- •Has a Static Physician's Global Assessment (sPGA) score ≥
- •Has a Body Surface Area (BSA) affected by Ps ≥ 10%.
排除标准
- •Male participant who is considering fathering a child or donating sperm during the study or through 30 days after the last dose of study drug.
- •History of clinically significant sensitivity to any drug.
- •History of epilepsy, any clinically significant cardiac (including any family history of long-QT syndrome or unexplained sudden death), respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- •History of gastric surgery (except pyloromyotomy for pyloric stenosis during infancy), vagotomy, bowel resection or any surgical procedure that might interfere with gastrointestinal motility, pH or absorption.
- •Infection(s) requiring treatment with intravenous (IV) anti-infectives within 30 days prior to the start of confinement (Day -2 or Day -1) or oral anti-infectives within 14 days prior to the start of confinement (Day -2 or Day -1)..
- •Requirement for any over-the-counter and/or prescription medication, vitamins and/or herbal supplements on a regular basis.
- •Use of any medications, vitamins and/or herbal supplements within the 2-week period prior to study drug administration. For Substudy 2, medications used to treat chronic, stable medical conditions are allowed during screening and participation in the study unless the medication is specifically prohibited.
研究组 & 干预措施
Arm B
Participants, who are healthy volunteers, receiving ABBV-553 dose B or placebo
干预措施: Placebo (Drug)
Arm A
Participants, who are healthy volunteers, receiving ABBV-553 dose A or placebo
干预措施: ABBV-553 (Drug)
Arm A
Participants, who are healthy volunteers, receiving ABBV-553 dose A or placebo
干预措施: Placebo (Drug)
Arm B
Participants, who are healthy volunteers, receiving ABBV-553 dose B or placebo
干预措施: ABBV-553 (Drug)
Arm C
Participants, who are healthy volunteers, receiving ABBV-553 dose C or placebo
干预措施: ABBV-553 (Drug)
Arm C
Participants, who are healthy volunteers, receiving ABBV-553 dose C or placebo
干预措施: Placebo (Drug)
Arm D
Participants, who are healthy volunteers, receiving ABBV-553 dose D or placebo
干预措施: ABBV-553 (Drug)
Arm D
Participants, who are healthy volunteers, receiving ABBV-553 dose D or placebo
干预措施: Placebo (Drug)
Arm E
Participants with psoriasis receiving ABBV-553 dose B or placebo
干预措施: ABBV-553 (Drug)
Arm E
Participants with psoriasis receiving ABBV-553 dose B or placebo
干预措施: Placebo (Drug)
Arm F
Participants with psoriasis receiving ABBV-553 dose C or placebo
干预措施: ABBV-553 (Drug)
Arm F
Participants with psoriasis receiving ABBV-553 dose C or placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Substudy 1: Maximum observed plasma concentration (Cmax) of ABBV-553
时间窗: Day 1
Maximum observed plasma concentration (Cmax) of ABBV-553
Substudy 1: Time to Cmax (peak time, Tmax)
时间窗: Day 1
Time to Cmax (peak time, Tmax)
Substudy 1: Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
时间窗: Day 1
Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
Substudy 2: Observed plasma concentration at the end of the dosing interval (Ctrough)
时间窗: Day 28
Observed plasma concentration at the end of the dosing interval (Ctrough)
Substudy 2: Maximum observed plasma concentration (Cmax) of ABBV-553
时间窗: Day 1
Maximum observed plasma concentration (Cmax) of ABBV-553
Substudy 2: Time to Cmax (peak time, Tmax)
时间窗: Day 1
Time to Cmax (peak time, Tmax)
Substudy 2: Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
时间窗: Day 1
Area under the concentration time curve (AUC) from time zero to 24 hours after dosing
Substudy 1: Observed plasma concentration at the end of the dosing interval (Ctrough)
时间窗: Day 7 and Day 14
Observed plasma concentration at the end of the dosing interval (Ctrough)
Substudy 1: Apparent clearance (CL/F)
时间窗: Day 14
Apparent clearance (CL/F)
Substudy 1: Fraction excreted unchanged in urine (fe)
时间窗: Day 14
Fraction excreted unchanged in urine (fe)
Substudy 2: Apparent clearance (CL/F)
时间窗: Day 28
Apparent clearance (CL/F)
Substudy 2: Volume of distribution (Vβ/F)
时间窗: Day 28
Volume of distribution (Vβ/F)
Substudy 1: Volume of distribution (Vβ/F)
时间窗: Day 14
Volume of distribution (Vβ/F)
Substudy 1: Apparent renal clearance (CLR)
时间窗: Day 14
Apparent renal clearance (CLR)
次要结局
- Substudy 2: Psoriasis Area and Severity Index (PASI)(Day 28)
- Substudy 2: Self-Assessment of Psoriasis Symptoms (SAPS) scores(Day 28)