Shanghai Xuhui Central Hospital /ID# 264785
Shanghai, Shanghai Municipality, 200031, China
NCT Number: NCT06632938
The main objectives of this study are to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of single subcutaneous (SC) and intravenous (IV) doses of ABBV-382 in healthy adult Chinese volunteers.
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Notify Me18 year–55 year
All sexes
Interventional
Phase 1
Shanghai, Shanghai Municipality, 200031, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Subcutaneous (SC) Injection
IV Infusion
Time frame: Up to Approximately Day 140
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 Day 112
Maximum observed serum concentration (Cmax) of ABBV-382.
Time frame: Up to Day 112
Time to Cmax (Tmax) of ABBV-382.
Time frame: Up to Day 112
Area under the serum concentration-time curve (AUC) from time 0 to the time of last measurable concentration (AUCt) of ABBV-382.
Time frame: Up to Day 112
AUC from time 0 to infinite time (AUCinf) of ABBV-382.
Time frame: Up to Day 112
Terminal phase elimination rate constant of ABBV-382.
Time frame: Up to Day 112
Terminal phase elimination half-life of ABBV-382.
Time frame: Up to Day 112
Confirmed Positive ADA Results.
AbbVie
Industry
A Randomized, Single-blind, Placebo-controlled, Phase 1 Study to Evaluate the Safety and Pharmacokinetics of Single Doses of ABBV-382 in Healthy Adult Chinese Volunteers
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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