Assessing how ABBV-142 is processed in healthy adults

A Phase 1a Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Doses of ABBV-142 in Healthy Adult Subjects and Single Doses of ABBV-142 in Healthy Adult Asian Subjects

This study is testing how a new drug called ABBV-142 is processed in healthy adults to see if it can be safely given through injections and infusions, focusing on Han Chinese and Japanese participants.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Locations: 1 site (Grayslake, Illinois)
• Trial ID: NCT06774313 on ClinicalTrials.gov

What this trial studies

This study evaluates the pharmacokinetic properties, safety, tolerability, and immunogenicity of ABBV-142 through subcutaneous injections and intravenous infusions in healthy adult participants. The goal is to determine if the predicted effective doses can be safely achieved in humans. Participants will receive either ABBV-142 or a placebo, and their responses will be monitored to assess any adverse events. The study specifically includes Han Chinese and Japanese individuals to understand the drug's effects in these populations.

Who should consider this trial

Good fit: Ideal candidates are healthy adult volunteers of first- or second-generation Han Chinese or Japanese descent, residing outside of their respective countries.

Not a fit: Patients who do not meet the eligibility criteria, such as those not of Han Chinese or Japanese descent or those with health issues, may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safety and efficacy of ABBV-142, potentially leading to new treatment options.

How similar studies have performed: While this study focuses on a specific population and drug, similar pharmacokinetic studies have shown success in assessing drug safety and efficacy.

Eligibility criteria

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 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

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 and maintain a typical Japanese lifestyle, including diet.
* 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 alcohol abuse within the last 6 months.

Where this trial is running

Grayslake, Illinois

• Acpru /Id# 271899 — Grayslake, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Abbvie Call Center

Conditions Healthy Volunteer; ABBV-142