ABBV-1451: testing how the drug behaves and tolerates in healthy adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 trial evaluates pharmacokinetics, safety, tolerability, and potential immunogenicity of single ascending doses of ABBV-1451 given as infusions and injections to healthy adults. It uses a randomized, placebo-controlled design across dose levels to characterize how the drug is absorbed, distributed, metabolized, and eliminated. The study aims to identify dose ranges that are safe and well tolerated before further testing in patients. Part 2 includes specific eligibility considerations for Japanese and Han Chinese participants living outside their home countries. Lead sponsor is AbbVie, with Grayslake, Illinois as the participating site.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
* Applies to Part 2 only:
* For Japanese participants:

  \-- Participant must be first or second-generation Japanese of full Japanese parentage, residing outside of Japan. First generation participants will have been born in Japan to two parents and four grandparents also born in Japan of full Japanese descent. Second-generation participants born outside of Japan must have two parents and four grandparents born in Japan of full Japanese descent. Participants must be in general good health.
* For Han Chinese participants:

  * Participant must be first or second-generation Han Chinese of full Chinese parentage, residing outside of China. First generation participants will have been born in China to two parents and four grandparents also born in China of full Chinese descent. Second-generation participants born outside of China must have two parents and four grandparents born in China of full Chinese descent. Participants must be in general good health.

Exclusion Criteria:

* History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of any clinically significant sensitivity or allergy to any medication or food.
* 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 treatment.

Where it's running

• Acpru /Id# 282128
  Grayslake, Illinois, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.