A Randomized, Single-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ABBV-382 in Healthy Adult Chinese Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Number of Participants with Adverse Events (AEs)
研究概览
简要总结
The main objectives of this study are to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single subcutaneous (SC) and intravenous (IV) doses of ABBV-382 in healthy adult Chinese 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
- Single (Participant)
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
- •Body Mass Index (BMI) is >= 18.0 to <= 27.9 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
- •Females, Non-Childbearing Potential:
- •Premenopausal female with permanent sterility or infertility due to one of following:
- •Permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)
- •Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis OR
- •Postmenopausal, defined as age <= 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level >= 30 IU/L.
- •Females of Childbearing Potential:
- •If a female does not meet the definition of a female of nonchildbearing potential above, she would be considered a female of childbearing potential.
- •Females of childbearing potential must not be pregnant or breastfeeding.
- •Females of childbearing potential consent to abide by contraception requirements.
- •Females of childbearing potential must agree to avoid pregnancy while taking study drug(s) from Study Day 1 through the end of the study (Day 140) plus an additional 90 days.
- •Females of childbearing potential must use a contraceptive method that is highly effective (with a failure rate of < 1% per year, when used consistently and correctly).
- •Male subjects who are sexually active with a female partner of childbearing potential must agree to use condoms, from Study Day 1 through the end of study (Day 140) plus an additional 90 days, even if the male subject has undergone a successful vasectomy.
- •Male subjects who are not considering fathering a child or donating sperm during the study from Study Day 1 through the end of the study (Day 140) plus an additional 90 days.
- •Laboratory values meeting those specified in the protocol.
- •A condition of generally good health based on the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG).
- •In the opinion of the investigator, this participant is a suitable candidate for enrollment in the study.
排除标准
- •History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
- •History of any clinically significant sensitivity or allergy to any medication or food, including no history of allergic reaction or anaphylaxis to therapeutic proteins, vaccines, or other parenteral treatments.
- •History of hereditary fructose intolerance
- •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 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.
- •Donated blood (including plasmapheresis), lost >= 550 mL blood volume, or received a transfusion of any blood product within 3 months prior to study drug administration.
- •Has been previously enrolled in this study.
- •Participant has been treated with any investigational drug within 3 months or 5 half-lives of the drug (whichever is longer) prior to the first dose of study drug or is currently enrolled in another clinical study or was previously enrolled in this study.
- •Participant has been treated with any anti-α4β7 integrin monoclonal antibody (Ab) or had prior exposure to ABBV-
- •Participant has received any live vaccine within 4 weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 4 months (120 days) after the last dose of study drug.
- •Participant requires any over-the-counter and/or prescription medication, vitamins and/or herbal supplements, with the exception of contraceptives or hormonal replacement therapies for females, on a regular basis.
- •Participant uses any medications, vitamins and/or herbal supplements, with the exception of contraceptives or hormonal replacement therapies for females, within the 2-week period prior to study drug administration.
- •Receipt of any drug by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study drug administration, with the exception of parenteral hormonal contraceptives or hormonal replacement therapies for females
- •Exposure to antibody-based immunotherapy or previous enrollment in antibody-based immunotherapy clinical trials within a period defined by 5 half-lives prior to the first dose of study drug.
研究组 & 干预措施
ABBV-382 Dose A
Participant will receive a single dose of ABBV-382 Dose A on Day 1 and will be confined to the study site and supervised for approximately 9 days. Participants will be followed-up for approximately 20 weeks.
干预措施: ABBV-382 (Drug)
ABBV-382 Dose A Placebo
Participant will receive a single dose of ABBV-382 Dose A placebo on Day 1 and will be confined to the study site and supervised for approximately 9 days. Participants will be followed-up for approximately 20 weeks.
干预措施: Placebo for ABBV-382 (Drug)
ABBV-382 Dose B
Participant will receive a single dose of ABBV-382 Dose B on Day 1 and will be confined to the study site and supervised for approximately 5 days. Participants will be followed-up for approximately 20 weeks.
干预措施: ABBV-382 (Drug)
ABBV-382 Dose B Placebo
Participant will receive a single dose of ABBV-382 Dose B placebo on Day 1 and will be confined to the study site and supervised for approximately 5 days. Participants will be followed-up for approximately 20 weeks.
干预措施: Placebo for ABBV-382 (Drug)
结局指标
主要结局
Number of Participants with Adverse Events (AEs)
时间窗: Up to Approximately Day 140
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.
Maximum Observed Serum Concentration (Cmax) of ABBV-382
时间窗: Up to Day 112
Maximum observed serum concentration (Cmax) of ABBV-382.
Time to Cmax (Tmax) of ABBV-382
时间窗: Up to Day 112
Time to Cmax (Tmax) of ABBV-382.
Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-382
时间窗: Up to Day 112
Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-382.
Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-382
时间窗: Up to Day 112
AUC from time 0 to infinite time (AUCinf) of ABBV-382.
Terminal Phase Elimination Rate Constant (β) of ABBV-382
时间窗: Up to Day 112
Terminal phase elimination rate constant of ABBV-382.
Terminal Phase Elimination Half-Life (t1/2) of ABBV-382
时间窗: Up to Day 112
Terminal phase elimination half-life of ABBV-382.
Anti-Drug Antibody (ADA) of ABBV-382
时间窗: Up to Day 112
Confirmed Positive ADA Results.
次要结局
未报告次要终点