The objective of this study is to assess the safety, tolerability, pharmacokinetics and immunogenicity of either single ascending intravenous (IV) doses of ABBV-243 or single ascending subcutaneous (SC) doses of ABBV-243 in healthy adult participants (Part 1), and a single intravenous (IV) dose in healthy Asian adult volunteers (Part 2 There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
66
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Subcutaneous (SC) Injection
Subcutaneous (SC) Injection
Acpru /Id# 279789
Grayslake, Illinois, United States
RECRUITINGNumber of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Time frame: Up to Day 204
Maximum Observed Serum Concentration (Cmax) of ABBV-243
Maximum observed serum concentration (Cmax) of ABBV-243
Time frame: Up to Day 204
Time to Cmax (Tmax) of ABBV-243
Time to Cmax (Tmax) of ABBV-243
Time frame: Up to Day 204
Area Under the Serum Concentration-Time Curve From Time 0 to Time of Last Measurable Concentration (AUCt) of ABBV-243
Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-243
Time frame: Up to Day 204
Area Under the Serum Concentration-Time Curve From Time 0 to Infinite Time (AUCinf) of ABBV-243
AUC from time 0 to infinite time (AUCinf) of ABBV-243
Time frame: Up to Day 204
Terminal Phase Elimination Rate Constant (β) of ABBV-243
Terminal phase elimination rate constant of ABBV-243
Time frame: Up to Day 204
Terminal Phase Elimination Half-Life (t1/2) of ABBV-243
Terminal phase elimination half-life of ABBV-243
Time frame: Up to Day 204
Anti-Drug Antibody (ADA) of ABBV-243
Confirmed Positive ADA Results.
Time frame: Up to Day 204
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