Assessing the safety and tolerability of ABBV-CLS-616 in healthy adults

A Phase 1 First in Human, Single and Multiple Ascending Dose, Food Effect, and Drug-Drug Interaction Study in Healthy Volunteers to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABBV-CLS-616

This study is testing a new oral medication called ABBV-CLS-616 in healthy adults to see if it's safe and how it works in the body.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Locations: 1 site (Grayslake, Illinois)
• Trial ID: NCT06698926 on ClinicalTrials.gov

What this trial studies

This Phase 1 clinical trial evaluates the safety, tolerability, and pharmacokinetics of ABBV-CLS-616 oral tablets in healthy adult participants. The study is randomized and consists of four parts, focusing on how the drug interacts with the body after oral dosing. Participants will receive either the active drug or a placebo, and some will also be administered itraconazole to assess potential interactions. The trial aims to gather essential data on the drug's effects in a controlled environment.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adult volunteers who meet specific health criteria and have normal laboratory values.

Not a fit: Patients with significant active or recurrent ocular diseases or those with a history of certain neurological conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the safety and pharmacokinetics of ABBV-CLS-616, paving the way for future therapeutic applications.

How similar studies have performed: Other studies assessing the safety and pharmacokinetics of new drugs in healthy volunteers have shown success, making this approach a standard practice in early-phase clinical research.

Eligibility criteria

Inclusion Criteria:

* Part 2 only: Participant must have normal platelet count at screening and upon initial confinement.
* Part 2 only: Participant must not have known or suspected coagulopathy, or prothrombin time (PT)/activated partial thromboplastin time (aPTT)/international normalized ratio (INR) values outside of normal range at screening.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, neurological examination, ophthalmic examination (Part 2 only) laboratory profile and a 12-lead Electrocardiogram.

Exclusion Criteria:

* Part 2 only: Clinically significant active or recurrent ocular disease.
* History of lumbar puncture and/or collection of cerebrospinal fluid within 30 days prior to Screening.
* History of current condition of chronic lower back pain.
* Evidence of conditions that might preclude the subject from undergoing a lumbar puncture.
* History: of clinically significant neurological epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, coagulopathy, or any uncontrolled medical illness.
* History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale completed at Screening, or any history of suicide attempts within the last two years.

Where this trial is running

Grayslake, Illinois

• Acpru /Id# 270532 — Grayslake, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Abbvie Call Center

Conditions Healthy Volunteer; ABBV-CLS-616