Healthy Volunteers
Conditions
Keywords
Healthy Volunteers, ABBV-277
Brief summary
The objective of this study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK ) properties following a single dose of ABBV-277 in healthy adult participants.
Interventions
DRUGABBV-277
• Intravenous (IV) infusion
DRUGPlacebo
• Intravenous (IV) infusion
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Body weight ≥ 35 kg * Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile neurological examination, and a 12-lead ECG
Exclusion criteria
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, metabolic, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness. * Participant must meet pregnancy/conception/partner considerations criteria as detailed in the eligibility section. * Participants using any medications, vitamins and/or herbal supplements within the 14-day period prior to study drug administration or within 5 half-lives of the respective medication, whichever is longer. * 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. * History of suicidal ideation currently or within one year prior to study drug administration as evidenced by answering "yes" to Questions 4 or 5 on the suicidal ideation portion of the C - SSRS completed at screening, or any history of suicide attempts within the last two years.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Plasma Concentration (Cmax) of ABBV-277 | Up to approximately 9 days | Cmax of ABBV-277 |
| Time to Cmax (Tmax) of ABBV-277 | Up to approximately 9 days | Tmax of ABBV-277 |
| Terminal Phase Elimination Rate Constant (Beta) of ABBV-277 | Up to approximately 9 days | Terminal phase elimination rate constant (beta) of ABBV-277 |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-277 | Up to approximately 9 days | Terminal phase elimination half-life of ABBV-277 |
| Area Under the Concentration-Time Curve From Time 0 to Time t (AUCt) of ABBV-277 | Up to approximately 9 days | AUCt of ABBV-277 |
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUCinf) of ABBV-277 | Up to approximately 9 days | AUCinf of ABBV-277 |
| Number of Participants With Adverse Events (AEs) | Up to Day 196 | An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant 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 |
Countries
United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed