The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity following multiple intravenous (IV) ascending doses of ABBV-8736 in healthy adult participants.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
24
Acpru /Id# 277377
Grayslake, Illinois, United States
Number of Participants with Adverse Events (AEs)
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.
Time frame: Up to Approximately 113 Days
Maximum Observed Concentration (Cmax) of ABBV-8736
Cmax of ABBV-8736.
Time frame: Up to Approximately 113 Days
Time to Cmax (Tmax) of ABBV-8736
Tmax of ABBV-8736.
Time frame: Up to Approximately 113 Days
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of ABBV-8736
AUCtau of ABBV-8736.
Time frame: Up to Approximately 113 Days
Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-8736
Ctrough of ABBV-8736.
Time frame: Up to Approximately 113 Days
Apparent Terminal Phase Elimination Rate Constant (β) of ABBV-8736
β of ABBV-8736.
Time frame: Up to Approximately 113 Days
Terminal Phase Elimination Half-Life (t1/2) of ABBV-8736
t1/2 of ABBV-8736.
Time frame: Up to Approximately 113 Days
Clearance (CL) for Intravenous (IV) Dosing
CL for IV dosing.
Time frame: Up to Approximately 113 Days
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Immunogenicity of ABBV-8736 as Determined by Anti-Drug Antibodies (ADAs)
Incidence and concentrations of ADAs. Neutralizing ADAs (NAb) may be evaluated.
Time frame: Up to Approximately 113 Days