A Phase 1 interventional study of ABBV-141 and Placebo for ABBV-141 in Healthy Volunteers, sponsored by AbbVie. Completed at 1 site in United States. Open to participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-01-23.
Sponsored by AbbVie · Phase 1, Interventional, and Basic science
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and immunogenicity after single ascending doses (SAD) of ABBV-141 in healthy adult Western and Asian participants.
AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.
Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
For Part 2 only:
-Han Chinese ethnicity or Japanese ethnicity based on the following criteria:
Exclusion Criteria:
Additionally for Part 1, only:
Western participants will receive a single IV dose of ABBV-141.
Drug: ABBV-141
Western participants will receive a single IV dose of placebo for ABBV-141.
Drug: Placebo for ABBV-141
Western participants will receive a single SC dose of ABBV-141.
Drug: ABBV-141
Western participants will receive a single SC dose of placebo for ABBV-141.
Drug: Placebo for ABBV-141
Asian participants will receive a single IV dose of ABBV-141.
Drug: ABBV-141
Asian participants will receive a single IV dose of placebo for ABBV-141.
Drug: Placebo for ABBV-141
Asian participants will receive a single SC dose of ABBV-141.
Drug: ABBV-141
Asian participants will receive a single SC dose of placebo for ABBV-141.
Drug: Placebo for ABBV-141
Infusion; intravenous (IV)
Infusion; IV
Injection; subcutaneous (SC)
Injection; SC
Maximum Observed Plasma Concentration (Cmax) of ABBV-141
Cmax of ABBV-141 will be assessed.
Time frame: Up to Day 85
Time to Cmax (Tmax) of ABBV-141
Tmax of ABBV-141 will be assessed.
Time frame: Up to Day 85
Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt)
AUCt of ABBV-141 will be determined.
Time frame: Up to Day 85
AUC of ABBV-141 from Time 0 to Infinity (AUCinf)
AUCinf of ABBV-141 will be assessed.
Time frame: Up to Day 85
Terminal Phase Elimination Rate Constant (β) of ABBV-141
Terminal phase elimination rate constant (β) of ABBV-141 will be assessed.
Time frame: Up to Day 85
Terminal Phase Elimination Half-life (t1/2) of ABBV-141
Terminal phase elimination half-life (t1/2) of ABBV-141 will be assessed.
Time frame: Up to Day 85
Dose Normalized Cmax of ABBV-141
Dose normalized Cmax of ABBV-141 will be assessed.
Time frame: Up to Day 85
Dose Normalized AUC of ABBV-141
Dose normalized AUC of ABBV-141 will be assessed.
Time frame: Up to Day 85
Number of Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time frame: Baseline to Day 85
Plan to share: No
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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