A Study to Assess the Adverse Events and How Subcutaneous (SC) Injections and Intravenous (IV) In… (NCT06774313) | Clinical Trial Compass
CompletedPhase 1
A Study to Assess the Adverse Events and How Subcutaneous (SC) Injections and Intravenous (IV) Infusions of ABBV-142 Move Through the Body of Healthy Adult Participants
United States73 participantsStarted 2025-01-22
Plain-language summary
This study is designed to assess the pharmacokinetic properties, safety, tolerability, and immunogenicity of ABBV-142 and determine whether predicted efficacious exposures can be safely achieved in humans.
Who can participate
Age range
18 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
All Parts:
• Volunteers in general good health.
Part 3, ONLY:
HAN CHINESE Participants:
* Participant must be first- or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health.
* First-generation participants will have been born in China to two parents and four grandparents, who were also born in China, and are of full Chinese descent.
* Second-generation participants born outside of China must have two parents and four grandparents born in China and are of full Chinese descent.
OR
JAPANESE Participants:
* Participant must be first- or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health.
* First-generation participants will have been born in Japan to two parents and four grandparents born in Japan and are of full Japanese descent.
* Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan and are of full Japanese descent.
Exclusion Criteria:
* History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.
* Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
* History of clinically significant (per investigator's judgment) drug or alco…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Participants with Adverse Events (AEs)
Timeframe: Up to Day 120
2
Maximum Observed Serum Concentration (Cmax) of ABBV-142
Timeframe: Up to Day 120
3
Time to Cmax (Tmax) of ABBV-142
Timeframe: Up to Day 120
4
Area Under the Serum Concentration-time Curve (AUC) of ABBV-142 from Time 0 to the Time of Last Measurable Concentration (AUCt)
Timeframe: Up to Day 120
5
AUC of ABBV-142 from Time 0 to Infinity (AUCinf)
Timeframe: Up to Day 120
6
Terminal Phase Elimination Rate Constant (β) of ABBV-142
Timeframe: Up to Day 120
7
Terminal Phase Elimination Half-life (t1/2) of ABBV-142