Healthy Volunteers
Conditions
Keywords
ABBV-141, Healthy Volunteers
Brief summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.
Interventions
DRUGABBV-141
Infusion; intravenous (IV)
DRUGPlacebo for ABBV-141
Infusion; IV
Sponsors
AbbVie
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 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 electrocardiogram (ECG). * Body Mass Index (BMI) is ≥ 18.0 to ≤ 32.0 kg/m2 after rounding to the tenths decimal. For Part 2 only: -Han Chinese ethnicity or Japanese ethnicity based on the following criteria: * Han Chinese: First-generation Han Chinese with both parents of Han Chinese descent. * Japanese: First- or second-generation Japanese with both parents and all four grandparents born in Japan and of Japanese descent.
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, topical creams, or food. Additionally for Part 1, only: * Presence of foreign bodies, local irritation or infections, active skin diseases, tattoos, and/or scars on the thighs which may preclude the skin biopsy collection site planned as per schedule of activities. * History of bruising easily, bleeding disorders, thrombocytopenia, or hypo-coagulation disorder. * History of sensitivity to or allergies to adhesives or evidence of fragile or easily damaged skin. * Evidence of hypertrophic scarring.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximum Observed Plasma Concentration (Cmax) of ABBV-141 | Up to Day 85 | Cmax of ABBV-141 will be assessed. |
| Time to Cmax (Tmax) of ABBV-141 | Up to Day 85 | Tmax of ABBV-141 will be assessed. |
| Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt) | Up to Day 85 | AUCt of ABBV-141 will be determined. |
| AUC of ABBV-141 from Time 0 to Infinity (AUCinf) | Up to Day 85 | AUCinf of ABBV-141 will be assessed. |
| Terminal Phase Elimination Rate Constant (β) of ABBV-141 | Up to Day 85 | Terminal phase elimination rate constant (β) of ABBV-141 will be assessed. |
| Terminal Phase Elimination Half-life (t1/2) of ABBV-141 | Up to Day 85 | Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed. |
| Dose Normalized Cmax of ABBV-141 | Up to Day 85 | Dose normalized Cmax of ABBV-141 will be assessed. |
| Dose Normalized AUC of ABBV-141 | Up to Day 85 | Dose normalized AUC of ABBV-141 will be assessed. |
| Number of Adverse Events (AEs) | Baseline to Day 85 | 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. |
Countries
United States
Outcome results
None listed