Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-1451
Brief summary
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.
Interventions
DRUGABBV-1451
Injection
OTHERPlacebo
Injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* 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: \-- 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. * 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.
Exclusion criteria
* 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/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to Approximately Day 211 | 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. |
| Maximum Observed Plasma Concentration (Cmax) of ABBV-1451 | Up to Approximately Day 211 | Cmax of ABBV-1451. |
| Time to Cmax (Tmax) of ABBV-1451 | Up to Approximately Day 211 | Tmax of ABBV-1451. |
| Terminal Phase Elimination Rate Constant (β) of ABBV-1451 | Up to Approximately Day 211 | β of ABBV-1451. |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-1451 | Up to Approximately Day 211 | t1/2 of ABBV-1451. |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-1451 | Up to Approximately Day 211 | AUCt of ABBV-1451. |
| Area Under the Plasma Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-1451 | Up to Approximately Day 211 | AUCinf of ABBV-1451. |
Countries
United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed