A First-in-Human, Phase 1, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of ABBV-859 After Single Ascending Doses in Healthy Adult Subjects
AbbVie
Summary
The objective of this study is to assess the pharmacokinetic (PK), immunogenicity, safety, and tolerability of ABBV-859 after single ascending doses in healthy adult volunteers.
Eligibility
- Age range
- 18–65 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Participants must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. * Body Mass Index (BMI) is \>= 18.0 to \<= 32 kg/m2 after rounding to the tenths decimal at screening. BMI is calculated as weight in kg divided by the square of height measured in meters. * 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…
Interventions
- DrugABBV-859
Oral Tablet
- DrugPlacebo for ABBV-859
Oral Tablet
- DrugABBV-859
Intravenous (IV) Infusion
- DrugPlacebo for ABBV-859
Intravenous (IV) Infusion
Locations (2)
- CenExel ACT- Anaheim Clinical Trials /ID# 284382Anaheim, California
- Acpru /Id# 284029Grayslake, Illinois