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Monoclonal Antibodies

Part 2, ABBV-141 (SC) for Healthy Subjects

Phase 1
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to day 85
Awards & highlights

Study 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.Check my eligibility
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).See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to day 85
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to day 85 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 more

Trial 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
958 Previous Clinical Trials
502,291 Total Patients Enrolled
ABBVIE INC.Study DirectorAbbVie
397 Previous Clinical Trials
147,010 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are the potential risks associated with the administration of Part 2, ABBV-141 (IV) in individuals?

"Our team at Power rates the safety of Part 2, ABBV-141 (IV) as a 1 on a scale from 1 to 3. This assessment is based on it being a Phase 1 trial with limited available data supporting both safety and efficacy."

Answered by AI

Are individuals currently being sought to participate in this ongoing medical study?

"Indeed, as per the information available on clinicaltrials.gov, this investigation is actively seeking eligible participants. The study was first posted on January 29th, 2024 and underwent its most recent update on January 31st, 2024."

Answered by AI

Is the age limit for participation in this medical study set at 40 years and above?

"To be eligible for participation in this clinical trial, individuals must meet the age requirement of being at least 18 years old and not exceeding 55 years of age."

Answered by AI

What is the current number of participants being enrolled in this research project?

"Indeed, the details provided on clinicaltrials.gov affirm that this particular clinical trial is presently seeking participants. The initial posting date for the trial was January 29, 2024, and it underwent its most recent revision on January 31, 2024. The study aims to recruit a total of 99 patients from a single location."

Answered by AI

Who else is applying?

What site did they apply to?
Acpru /Id# 261162
What portion of applicants met pre-screening criteria?
Did not meet criteria
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian Participants
2024. "A Study to Evaluate Adverse Events and How Single Ascending Doses of ABBV-141 Move Through the Body of Healthy Adult Western and Asian Participants". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06148181.
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~66 spots leftby Feb 2025
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