Acpru /Id# 279789
Grayslake, Illinois, 60030, United States
Location status: Recruiting
NCT Number: NCT07306754
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.
Interested in participating?
Request Info18 year–60 year
All sexes
Interventional
Phase 1
Grayslake, Illinois, 60030, United States
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Healthy Japanese and Han Chinese male or female; between 18 and 60 years of age, inclusive at the time of Screening.
OR
Exclusion criteria
Intravenous (IV) Infusion
Intravenous (IV) Infusion
Time frame: Up to Day 204
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
Time frame: Up to Day 204
Time to Cmax (Tmax) of ABBV-243
Time frame: Up to Day 204
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
AUC from time 0 to infinite time (AUCinf) of ABBV-243
Time frame: Up to Day 204
Terminal phase elimination rate constant of ABBV-243
Time frame: Up to Day 204
Terminal phase elimination half-life of ABBV-243
Time frame: Up to Day 204
Confirmed Positive ADA Results.
Contact information is provided by the study sponsor or research team.
AbbVie
Industry
A Randomized, Double-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single Ascending Doses (SAD) of ABBV-243 in Healthy Adult Subjects and a Single Dose in Healthy Asian Adult Subjects
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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