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OpenTrials
Completed

NCT Number: NCT06698926

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

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Acpru /Id# 270532

Grayslake, Illinois, 60030, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.
  • Part 2 only: History of lumbar puncture and/or collection of cerebrospinal fluid within 30 days prior to Screening.
  • Part 2 only: 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.

Treatment and study plan

ABBV-CLS-616

Drug

Oral Tablet

Placebo

Drug

Oral Tablet

Itraconazole

Drug

Oral Capsule

Primary outcomes

  1. Number of Participants with Adverse Events (AEs)

    Time frame: Up to approximately 90 days

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Collaborators

  • Calico Life Sciences LLC

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 21, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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