Evaluating ABBV-701 in healthy adults

A Phase 1, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Single Ascending Subcutaneous Doses of ABBV-701 in Healthy Adult Western and Asian Subjects

This study is testing a new drug called ABBV-701 in healthy adults to see if it's safe and how the body reacts to it.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 58 (estimated)
• Ages: 18 Years to 60 Years
• Sex: All
• Sponsor: AbbVie (industry)
• Locations: 1 site (Grayslake, Illinois)
• Trial ID: NCT06895343 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety, tolerability, pharmacokinetics, and immunogenicity of ABBV-701, administered as a subcutaneous injection, in healthy adult participants from Western and Asian backgrounds. The study will involve administering single ascending doses of the drug and monitoring participants for any adverse effects and how the drug is processed in the body. The trial will include specific eligibility criteria to ensure participants are in good health and meet certain demographic requirements.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18-65 with a BMI between 18.0 and 32.0 kg/m², specifically those of Japanese or Han Chinese descent residing outside their respective countries.

Not a fit: Patients with a history of significant health issues or those not meeting the specific demographic criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the safety and effectiveness of ABBV-701, potentially leading to new treatment options.

How similar studies have performed: While this study focuses on a specific population and drug, similar studies evaluating the safety and pharmacokinetics of new treatments in healthy volunteers have shown success in the past.

Eligibility criteria

Inclusion Criteria:

* Body Mass Index (BMI) ≥ 18.0 to ≤ 32.0 kg/m\^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters.
* 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
* Part 2 only:

For 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 consuming a typical Japanese diet.

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.

Exclusion Criteria:

* History of any clinically significant cardiovascular, respiratory (except mild asthma as a child), renal, endocrine, 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.

Where this trial is running

Grayslake, Illinois

• Acpru /Id# 273354 — Grayslake, Illinois, United States (RECRUITING)

Study contacts

• Study coordinator: ABBVIE CALL CENTER

Conditions: Healthy Volunteer, ABBV-701