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

NCT ID: NCT06698926

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2026-01-08

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteer

Keywords

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Healthy Volunteer ABBV-CLS-616

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Part 1: Group 1

Participants will receive either ABBV-CLS-616 Dose A or placebo after fasting on Day 1 and will be confined for 19 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

Part 1: Group 2

Participants will receive either ABBV-CLS-616 Dose B or placebo after fasting on Day 1 and will be confined for 19 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

Part 1: Group 3

Participants will receive either ABBV-CLS-616 Dose C or placebo after fasting on Day 1 and will be confined for 8 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

Part 1: Group 4

Participants will receive either ABBV-CLS-616 Dose D or placebo after fasting on Day 1 and will be confined for 8 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

Part 1: Group 5

Participants will receive either ABBV-CLS-616 Dose E or placebo after fasting on Day 1 and will be confined for 8 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

Part 1: Group 6

Participants will receive either ABBV-CLS-616 Dose F or placebo after fasting on Day 1 and will be confined for 8 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

Part 2: Group 7

Participants will receive either ABBV-CLS-616 Dose G or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

Part 2: Group 8

Participants will receive either ABBV-CLS-616 Dose H or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

Part 2: Group 9

Participants will receive either ABBV-CLS-616 Dose D or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

Part 2: Group 10

Participants will receive either ABBV-CLS-616 Dose E or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

Part 2: Group 11

Participants will receive either ABBV-CLS-616 Dose F or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Placebo

Intervention Type DRUG

Oral Tablet

Part 3: Sequence 1

In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 after fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, without fasting and will be confined for 8 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Part 3: Sequence 2

In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 without fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 8 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Part 4: Itraconazole

In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 7 days. In Period 2, participants will receive Itraconazole daily for 10 days without fasting and will receive ABBV-CLS-616 Dose C on Day 4 after fasting. Participants will be confined for 11 days.

Group Type EXPERIMENTAL

ABBV-CLS-616

Intervention Type DRUG

Oral Tablet

Itraconazole

Intervention Type DRUG

Oral Capsule

Interventions

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ABBV-CLS-616

Oral Tablet

Intervention Type DRUG

Placebo

Oral Tablet

Intervention Type DRUG

Itraconazole

Oral Capsule

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Calico Life Sciences LLC

INDUSTRY

Sponsor Role collaborator

AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Acpru /Id# 270532

Grayslake, Illinois, United States

Site Status

Countries

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United States

Related Links

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https://www.abbvieclinicaltrials.com/study/?id=M25-206

Related Info

Other Identifiers

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M25-206

Identifier Type: -

Identifier Source: org_study_id