A First-in-Human, Phase 1a/b, Single-Dose Study of ABBV-547 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Adult Participants and Efficacy in Adult Participants
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 121
- 试验地点
- 23
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to assess how safe, effective, and tolerable ABBV-547 is in adult participants in the United States and Japan.
There will be 2 parts to this study. In Part 1, participants are placed in one of 7 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 4 chance participants will receive placebo. In Part 2, participants are placed in one of 3 groups where they will receive ABBV-547 at different doses or placebo. There is a 1 in 7 chance participants will receive placebo. Approximately 121 adult participants will be enrolled at approximately 21 sites in the United States and Japan.
Participants will be administered one dose of ABBV-547 or placebo.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
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
- Triple (Participant, Care Provider, Investigator)
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
- •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).
- •Part 1: BMI is >= 18.0 to <= 29.9 kg/m^2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •Part 2: must have discontinued use of phototherapy (e.g., UVA or UVB) at least 2 weeks prior to the baseline visit (Day 1) and PUVA phototherapy at least 4 weeks prior to the baseline visit (Day 1).
排除标准
- •History of any clinically significant sensitivity or allergy to any medication or food.
- •Part 2: uses any herbal supplements within the 2-week period prior to study treatment administration.
- •Part 2: received any biologics including investigational agents within 2.5 half-lives prior to Baseline.
研究组 & 干预措施
Group 1: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 Placebo (Drug)
Group 3: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 Placebo (Drug)
Group 4: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 (Drug)
Group 4: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 Placebo (Drug)
Group 5: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 (Drug)
Group 5: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 Placebo (Drug)
Group 6: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 Placebo (Drug)
Group 6: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 (Drug)
Group 1: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 (Drug)
Group 2: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 (Drug)
Group 2: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 Placebo (Drug)
Group 3: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 (Drug)
Group 9: ABBV-547 & Placebo
Han Chinese participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 (Drug)
Group 10: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 Placebo (Drug)
Group 9: ABBV-547 & Placebo
Han Chinese participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 Placebo (Drug)
Group 10: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 (Drug)
Group 7: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 (Drug)
Group 7: ABBV-547 & Placebo
Participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 Placebo (Drug)
Group 8: ABBV-547 & Placebo
Japanese participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 (Drug)
Group 8: ABBV-547 & Placebo
Japanese participants will receive either ABBV-547 or placebo.
干预措施: ABBV-547 Placebo (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to Approximately Day 365
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.
次要结局
未报告次要终点