Healthy Volunteer
Conditions
Keywords
Healthy Volunteer, ABBV-8736
Brief summary
The purpose of this study is to assess the pharmacokinetics (PK), bioavailability, immunogenicity, safety, and tolerability of ABBV-8736 following subcutaneous (SC) administration relative to intravenous (IV) administration.
Interventions
DRUGABBV-8736
Intravenous Injection
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Body mass index (BMI) is \>= 18.0 to \<= 32.0 kg/m2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters. * Body weight \>= 35 kg. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead electrocardiogram (ECG).
Exclusion criteria
* Participant requires any over-the-counter and/or prescription medication, vitamins, and/or herbal supplements, on a regular basis. * Participant uses any medications, vitamins and/or herbal supplements within the 14-day period prior to study treatment administration. * Participant has received any treatment by injection within 30 days or within a period defined by 5 half-lives, whichever is longer, prior to study treatment administration. * Participant has prior exposure to a Triggering Receptor Expressed on Myeloid Cells 1 (TREM1) agent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Terminal Elimination Half-Life (t1/2) of ABBV-8736 | Up to At Least 3 Months | t1/2 of ABBV-8736. |
| Apparent Clearance of the Analyte in Serum (CL) of ABBV-8736 | Up to At Least 3 Months | CL of ABBV-8736. |
| Number of Participants with Adverse Events (AEs) | Up to At Least 3 Months | 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-8736 | Up to At Least 3 Months | Cmax of ABBV-8736. |
| Time to Maximum Observed Serum Concentration (Tmax) of ABBV-8736 | Up to At Least 3 Months | Tmax of ABBV-8736. |
| Area Under the Plasma Concentration-Time Curve (AUC) From Time 0 to the Time Last (AUClast) of ABBV-8736 | Up to At Least 3 Months | AUClast of ABBV-8736. |
| AUC From Time 0 to the Time Infinity (AUCinf) of ABBV-8736 | Up to At Least 3 Months | AUCinf of ABBV-8736. |
| Terminal Phase Elimination Rate Constant (β) of ABBV-8736 | Up to At Least 3 Months | β of ABBV-8736. |
Countries
United States
Contacts
CONTACTABBVIE CALL CENTER
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed