Assessing the safety and tolerability of ABBV-722 in healthy adults
A First-In-Human Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of ABBV-722 Following Single and Multiple Ascending Doses in Healthy Adult Subjects and Single Doses in Healthy Adult Asian Subjects
This study is testing a new oral medication called ABBV-722 in healthy adults to see if it's safe and how it works in their bodies.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 96 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Locations | 1 site (Grayslake, Illinois) |
| Trial ID | NCT06673238 on ClinicalTrials.gov |
What this trial studies
This Phase 1 clinical trial evaluates the safety, tolerability, and pharmacokinetics of ABBV-722, an oral medication, in healthy adult participants. The study involves administering single and multiple ascending doses of ABBV-722 to assess how the drug moves through the body and to monitor any adverse events. It specifically includes healthy Han Chinese and Japanese individuals aged 18 to 65, ensuring a focus on a specific demographic. The trial aims to gather essential data that will inform future studies and potential therapeutic applications.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy adult individuals of Han Chinese or Japanese descent, aged 18 to 65, who meet specific health criteria.
Not a fit: Patients who do not meet the eligibility criteria, such as those outside the specified age range or of non-Han Chinese descent, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the safety and tolerability of ABBV-722, paving the way for its use in treating various conditions.
How similar studies have performed: While this study is focused on a specific population and drug, similar Phase 1 studies have successfully assessed the safety and pharmacokinetics of new drugs in healthy volunteers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Laboratory values meet the criteria specified in the protocol. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG). * Part 2 only: Healthy Han Chinese and Japanese individuals between 18 and 65 years of age, inclusive at the time of Screening. * 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 and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet. * 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 * Participant must be first- or second-generation Japanese of full Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet. * First-generation participants will have been born in Japan to two parents and four grandparents, who were also 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. * Consumption of alcohol, grapefruit products, Seville oranges, starfruit products or quinine/tonic water within the 72-hour period prior to study drug administration. * Use of tobacco or nicotine-containing products within 180 days prior to the first dose of study drug.
Where this trial is running
Grayslake, Illinois
- Acpru /Id# 270279 — Grayslake, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Abbvie Call Center
- Email: abbvieclinicaltrials@abbvie.com
- Phone: 844-663-3742
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.