[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07570147":3,"trial-entities:NCT07570147":115,"trial-summary:NCT07570147":118},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":22,"primary_purpose":23,"phases":24,"enrollment_info":26,"interventions":29,"primary_outcomes":51,"secondary_outcomes":74,"sex":75,"minimum_age":76,"maximum_age":77,"healthy_volunteers":78,"eligibility_criteria":79,"std_ages":91,"locations":93,"central_contacts":103,"overall_officials":109,"references":113,"see_also_links":114},"NCT07570147","M26-116","A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Ascending Doses of ABBV-1451 Infusions and Injections in Healthy Adult Participants","A First in Human, Single Ascending Dose Study of ABBV-1451 to Evaluate the Pharmacokinetics, Immunogenicity, Safety, and Tolerability in Healthy Subjects and in Japanese and Han Chinese Healthy Subjects","RECRUITING","2027-04","2026-05","2026-05-28","2026-05-01","AbbVie","INDUSTRY",false,"The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-1451 after single ascending doses in healthy adult volunteers.",null,[19],"Healthy Volunteer",[19,21],"ABBV-1451","INTERVENTIONAL","BASIC_SCIENCE",[25],"PHASE1",{"count":27,"type":28},90,"ESTIMATED",[30,37,45,49],{"type":31,"name":21,"description":32,"armGroupLabels":33},"DRUG","Injection",[34,35,36],"Part 1: Group 1","Part 1: Group 2","Part 2: Group 8",{"type":31,"name":21,"description":38,"armGroupLabels":39},"Infusion",[40,41,42,43,44],"Part 1: Group 3","Part 1: Group 4","Part 1: Group 5","Part 1: Group 6","Part 2: Group 7",{"type":46,"name":47,"description":32,"armGroupLabels":48},"OTHER","Placebo",[34,35,36],{"type":46,"name":47,"description":38,"armGroupLabels":50},[40,41,42,43,44],[52,56,59,62,65,68,71],{"measure":53,"description":54,"timeFrame":55},"Number of Participants with Adverse Events (AEs)","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. The investigator assesses the relationship of each event to the use of study.","Up to Approximately Day 211",{"measure":57,"description":58,"timeFrame":55},"Maximum Observed Plasma Concentration (Cmax) of ABBV-1451","Cmax of ABBV-1451.",{"measure":60,"description":61,"timeFrame":55},"Time to Cmax (Tmax) of ABBV-1451","Tmax of ABBV-1451.",{"measure":63,"description":64,"timeFrame":55},"Terminal Phase Elimination Rate Constant (β) of ABBV-1451","β of ABBV-1451.",{"measure":66,"description":67,"timeFrame":55},"Terminal Phase Elimination Half-Life (t1\u002F2) of ABBV-1451","t1\u002F2 of ABBV-1451.",{"measure":69,"description":70,"timeFrame":55},"Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-1451","AUCt of ABBV-1451.",{"measure":72,"description":73,"timeFrame":55},"Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-1451","AUCinf of ABBV-1451.",[],"ALL","18 Years","60 Years",true,{"inclusion":80,"exclusion":86,"raw_text":90},[81,82,83,84,85],"A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.","Applies to Part 2 only:","For Japanese participants:","For Han Chinese participants:","Participant must be first or second-generation Han Chinese of full Chinese parentage, residing outside of China. First generation participants will have been born in China to two parents and four grandparents also born in China of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Chinese descent. Participants must be in general good health.",[87,88,89],"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.","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 treatment.","Inclusion Criteria:\n\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.\n* Applies to Part 2 only:\n* For Japanese participants:\n\n  \\-- Participant must be first or second-generation Japanese of full Japanese parentage, residing outside of Japan. First generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. Participants must be in general good health.\n* For Han Chinese participants:\n\n  * Participant must be first or second-generation Han Chinese of full Chinese parentage, residing outside of China. First generation participants will have been born in China to two parents and four grandparents also born in China of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Chinese descent. Participants must be in general good health.\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.\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 treatment.",[92],"ADULT",[94],{"facility":95,"status":8,"city":96,"state":97,"zip":98,"country":99,"geoPoint":100},"Acpru \u002FId# 282128","Grayslake","Illinois","60030","United States",{"lat":101,"lon":102},42.34447,-88.04175,[104],{"name":105,"role":106,"phone":107,"email":108},"ABBVIE CALL CENTER","CONTACT","844-663-3742","abbvieclinicaltrials@abbvie.com",[110],{"name":111,"affiliation":13,"role":112},"ABBVIE INC.","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":116,"biomarkers":117},[19],[],{"nct_id":4,"found":78,"summary":119,"prompt_version":17},{"design":120,"status":121,"heading":122,"summary":123,"follow_up":124,"word_count":125,"commitments":126,"compensation":127,"drugs_mentioned":128},"This is an interventional study involving single ascending doses of ABBV-1451 or placebo, given as injections or infusions, to approximately 90 healthy adult participants.","completed","A Study of ABBV-1451 in Healthy Adults","This study is looking for healthy adult volunteers, aged 18 to 60, to help us understand a new drug called ABBV-1451. We want to learn how your body handles ABBV-1451 (pharmacokinetics or PK) when given as an injection or an infusion (into a vein). We also want to see if it's safe and how well people tolerate it. Some participants will receive ABBV-1451, while others will receive a placebo (an inactive substance). The study will measure side effects and how much ABBV-1451 is in your blood over about 211 days. The study aims to enroll 90 participants, but its current recruitment status is unclear.","Participants will be followed for safety and drug levels for up to approximately 211 days.",104,"Not specified in the trial record.","Not stated in the trial record.",[21,47]]