Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-142
Brief summary
This study is designed to assess the pharmacokinetic properties, safety, tolerability, and immunogenicity of ABBV-142 and determine whether predicted efficacious exposures can be safely achieved in humans.
Interventions
DRUGABBV-142
Intravenous (IV) Infusion
DRUGPlacebo
IV Infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
All Parts: • Volunteers in general good health. Part 3, ONLY: HAN CHINESE Participants: * Participant must be first- or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health. * First-generation participants will have been born in China to two parents and four grandparents, who were also born in China, and are of full Chinese descent. * Second-generation participants born outside of China must have two parents and four grandparents born in China and are of full Chinese descent. OR JAPANESE Participants: * Participant must be first- or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health. * First-generation participants will have been born in Japan to two parents and four grandparents born in Japan and are of full Japanese descent. * Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan and are of full Japanese descent.
Exclusion criteria
* 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. * Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug. * History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Adverse Events (AEs) | Up to Day 120 | 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-142 | Up to Day 120 | Cmax of ABBV-142 will be assessed. |
| Time to Cmax (Tmax) of ABBV-142 | Up to Day 120 | Tmax of ABBV-142 will be assessed. |
| Area Under the Serum Concentration-time Curve (AUC) of ABBV-142 from Time 0 to the Time of Last Measurable Concentration (AUCt) | Up to Day 120 | AUCt of ABBV-142 will be determined. |
| AUC of ABBV-142 from Time 0 to Infinity (AUCinf) | Up to Day 120 | AUCinf of ABBV-142 will be assessed. |
| Terminal Phase Elimination Rate Constant (β) of ABBV-142 | Up to Day 120 | Terminal phase elimination rate constant (β) of ABBV-142 will be assessed. |
| Terminal Phase Elimination Half-life (t1/2) of ABBV-142 | Up to Day 120 | Terminal phase elimination half-life (t1/2) of ABBV-142 will be assessed. |
| Dose Normalized Cmax of ABBV-142 | Up to Day 120 | Dose normalized Cmax of ABBV-142 will be assessed. |
| Dose Normalized AUC of ABBV-142 | Up to Day 120 | Dose normalized AUC of ABBV-142 will be assessed. |
Countries
United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed