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Monoclonal Antibodies
ABBV-141 for Healthy Adults
Phase 1
Waitlist Available
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Must not have
For Part 1 only: Presence of foreign bodies, local irritation or infections, active skin diseases, tattoos, and/or scars on the thighs which may preclude the skin biopsy collection site planned as per schedule of activities.
History of bruising easily, bleeding disorders, thrombocytopenia, or hypo-coagulation disorder.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 85
Summary
This trial is being conducted to test the safety and tolerability of a drug called ABBV-141 in healthy adults. The study will also look at how the drug is processed in the body and
Who is the study for?
This trial is for healthy adults who are either Western or of specific Asian descent (Han Chinese or Japanese). Participants must be in good health as determined by medical exams, have a BMI between 18.0 and 32.0, and for Asians, they need to have parents/grandparents of the same descent.
What is being tested?
The study is testing ABBV-141, a new drug. It's given in different amounts to see how it's tolerated and how it moves through the body compared to a placebo (a substance with no active drug).
What are the potential side effects?
Since this is an early-stage trial for ABBV-141, potential side effects aren't fully known yet but may include reactions at the injection site, headaches, nausea, fatigue or other signs indicating intolerance.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I do not have skin issues on my thighs that would interfere with a biopsy.
Select...
I have a history of easy bruising, bleeding disorders, or issues with blood clotting.
Select...
I have thick, raised scars.
Select...
I do not have any significant ongoing health issues like heart, lung (except mild childhood asthma), kidney, liver, stomach, blood, or mental health problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to day 85
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 85
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
AUC of ABBV-141 from Time 0 to Infinity (AUCinf)
Area Under the Serum Concentration-time Curve (AUC) of ABBV-141 from time 0 to the time of last measurable concentration (AUCt)
Dose Normalized AUC of ABBV-141
+6 moreTrial Design
8Treatment groups
Experimental Treatment
Placebo Group
Group I: Part 2, ABBV-141 (SC)Experimental Treatment1 Intervention
Asian participants will receive a single SC dose of ABBV-141.
Group II: Part 2, ABBV-141 (IV)Experimental Treatment1 Intervention
Asian participants will receive a single IV dose of ABBV-141.
Group III: Part 1, ABBV-141 (subcutaneous [SC])Experimental Treatment1 Intervention
Western participants will receive a single SC dose of ABBV-141.
Group IV: Part 1, ABBV-141 (Intravenous [IV])Experimental Treatment1 Intervention
Western participants will receive a single IV dose of ABBV-141.
Group V: Part 2, Placebo for ABBV-141 (SC)Placebo Group1 Intervention
Asian participants will receive a single SC dose of placebo for ABBV-141.
Group VI: Part 1, Placebo for ABBV-141 (IV)Placebo Group1 Intervention
Western participants will receive a single IV dose of placebo for ABBV-141.
Group VII: Part 1, Placebo for ABBV-141 (SC)Placebo Group1 Intervention
Western participants will receive a single SC dose of placebo for ABBV-141.
Group VIII: Part 2, Placebo for ABBV-141 (IV)Placebo Group1 Intervention
Asian participants will receive a single IV dose of placebo for ABBV-141.
Find a Location
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
AbbVieLead Sponsor
1,040 Previous Clinical Trials
523,480 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
461 Previous Clinical Trials
164,265 Total Patients Enrolled