[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100564727":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":45,"centralContacts":34,"locations":49,"responsibleParty":63,"collaborators":34,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":34,"eligibilityCriteria":71,"healthyVolunteers":72,"sex":73,"minAge":74,"maxAge":75,"enrollmentInfo":76,"targetDuration":34,"studyType":79,"phases":80,"briefSummary":82,"conditions":83,"keywords":85,"overallStatus":86,"whyStopped":34,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"AbbVie","INDUSTRY",[8,14,20,24],{"label":9,"type":10,"description":11,"interventionNames":12},"ABBV-382 Dose A","EXPERIMENTAL","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.",[13],"Drug: ABBV-382",{"label":15,"type":16,"description":17,"interventionNames":18},"ABBV-382 Dose A Placebo","PLACEBO_COMPARATOR","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.",[19],"Drug: Placebo for ABBV-382",{"label":21,"type":10,"description":22,"interventionNames":23},"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.",[13],{"label":25,"type":16,"description":26,"interventionNames":27},"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.",[19],[29,35,38,42],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"DRUG","ABBV-382","Subcutaneous (SC) Injection",[9],null,{"type":30,"name":31,"description":36,"armGroupLabels":37,"otherNames":34},"Intravenous (IV) Infusion",[21],{"type":30,"name":39,"description":40,"armGroupLabels":41,"otherNames":34},"Placebo for ABBV-382","IV Infusion",[25],{"type":30,"name":39,"description":43,"armGroupLabels":44,"otherNames":34},"SC Injection",[15],[46],{"name":47,"affiliation":5,"role":48},"ABBVIE INC.","STUDY_DIRECTOR",[50],{"facility":51,"status":34,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":34},"Shanghai Xuhui Central Hospital \u002FID# 264785","Shanghai","Shanghai Municipality","200031","China","CN",{"type":58,"coordinates":59},"Point",[60,61],121.45806,31.22222,{"lat":61,"lon":60},{"type":64,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR","100564727","phase-1-a-study-to-evaluate-adverse-events-and-how-the-drug-moves-through-the-body-from-subcutaneous-sc-and-intravenous-iv-doses-of-abbv-382-in-healthy-adult-chinese-volunteers-100564727",false,"NCT06632938","A Study to Evaluate Adverse Events and How the Drug Moves Through the Body From Subcutaneous (SC) and Intravenous (IV) Doses of ABBV-382 in Healthy Adult Chinese Volunteers","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","Inclusion Criteria:\n\n* Body Mass Index (BMI) is \\>= 18.0 to \\\u003C= 27.9 kg\u002Fm\\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* Females, Non-Childbearing Potential:\n\n  * Premenopausal female with permanent sterility or infertility due to one of following:\n\n    * Permanently sterile (hysterectomy, bilateral salpingectomy, or bilateral oophorectomy)\n    * Non-surgical permanent infertility due to Mullerian agenesis, androgen insensitivity, or gonadal dysgenesis OR\n  * Postmenopausal, defined as age \\\u003C= 55 years with no menses for 12 or more months without an alternative medical cause AND a follicle-stimulating hormone (FSH) level \\>= 30 IU\u002FL.\n* Females of Childbearing Potential:\n\n  * If a female does not meet the definition of a female of nonchildbearing potential above, she would be considered a female of childbearing potential.\n  * Females of childbearing potential must not be pregnant or breastfeeding.\n  * Females of childbearing potential consent to abide by contraception requirements.\n  * 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.\n  * Females of childbearing potential must use a contraceptive method that is highly effective (with a failure rate of \\\u003C 1% per year, when used consistently and correctly).\n  * 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.\n  * 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.\n* Laboratory values meeting those specified in the protocol.\n* 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).\n* In the opinion of the investigator, this participant is a suitable candidate for enrollment in the study.\n\nExclusion Criteria:\n\n* 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.\n* 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.\n* History of hereditary fructose intolerance\n* 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.\n* History of any clinically significant illness\u002Finfection\u002Fmajor febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.\n* 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.\n* Has been previously enrolled in this study.\n* 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.\n* Participant has been treated with any anti-α4β7 integrin monoclonal antibody (Ab) or had prior exposure to ABBV-382.\n* 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.\n* Participant requires any over-the-counter and\u002For prescription medication, vitamins and\u002For herbal supplements, with the exception of contraceptives or hormonal replacement therapies for females, on a regular basis.\n* Participant uses any medications, vitamins and\u002For herbal supplements, with the exception of contraceptives or hormonal replacement therapies for females, within the 2-week period prior to study drug administration.\n* 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\n* 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.",true,"ALL","18 Years","55 Years",{"count":77,"type":78},24,"ACTUAL","INTERVENTIONAL",[81],"PHASE1","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.",[84],"Healthy Volunteer",[84,31],"COMPLETED","2025-05-27",{"date":89,"type":78},"2025-05-30",{"date":91,"type":78},"2024-10-08",{"date":93,"type":78},"2025-05-15",{"name":5,"class":6},1]