A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants

Description

This is a Phase 1, first in human, randomized, four-part study to investigate the safety, tolerability, and pharmacokinetics of ABBV-CLS-616 after oral dosing in healthy volunteers.

Conditions

Healthy Volunteer

Study Overview

Study Details

Study overview

This is a Phase 1, first in human, randomized, four-part study to investigate the safety, tolerability, and pharmacokinetics of ABBV-CLS-616 after oral dosing in healthy volunteers.

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

A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants

Condition
Healthy Volunteer
Intervention / Treatment

-

Contacts and Locations

Grayslake

Acpru /Id# 270532, Grayslake, Illinois, United States, 60030

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2026-03-15