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

NCT06698926 | Completed Phase 1

• 1 other identifier: M25-206
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

Healthy Volunteer; ABBV-CLS-616

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Adverse Events (AEs)

  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.

  Up to approximately 90 days

Study Arms (14)

Part 1: Group 1

EXPERIMENTAL

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

Drug: ABBV-CLS-616; Drug: Placebo

Part 1: Group 2

EXPERIMENTAL

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

Drug: ABBV-CLS-616; Drug: Placebo

Part 1: Group 3

EXPERIMENTAL

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

Drug: ABBV-CLS-616; Drug: Placebo

Part 1: Group 4

EXPERIMENTAL

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

Drug: ABBV-CLS-616; Drug: Placebo

Part 1: Group 5

EXPERIMENTAL

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

Drug: ABBV-CLS-616; Drug: Placebo

Part 1: Group 6

EXPERIMENTAL

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

Drug: ABBV-CLS-616; Drug: Placebo

Part 2: Group 7

EXPERIMENTAL

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.

Drug: ABBV-CLS-616; Drug: Placebo

Part 2: Group 8

EXPERIMENTAL

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.

Drug: ABBV-CLS-616; Drug: Placebo

Part 2: Group 9

EXPERIMENTAL

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.

Drug: ABBV-CLS-616; Drug: Placebo

Part 2: Group 10

EXPERIMENTAL

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.

Drug: ABBV-CLS-616; Drug: Placebo

Part 2: Group 11

EXPERIMENTAL

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.

Drug: ABBV-CLS-616; Drug: Placebo

Part 3: Sequence 1

EXPERIMENTAL

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.

Drug: ABBV-CLS-616

Part 3: Sequence 2

EXPERIMENTAL

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.

Drug: ABBV-CLS-616

Part 4: Itraconazole

EXPERIMENTAL

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.

Drug: ABBV-CLS-616; Drug: Itraconazole

Interventions

ABBV-CLS-616 DRUG

Oral Tablet

Part 1: Group 1; Part 1: Group 2; Part 1: Group 3; Part 1: Group 4; Part 1: Group 5; Part 1: Group 6; Part 2: Group 10; Part 2: Group 11; Part 2: Group 7; Part 2: Group 8; Part 2: Group 9; Part 3: Sequence 1; Part 3: Sequence 2; Part 4: Itraconazole

Placebo DRUG

Oral Tablet

Part 1: Group 1; Part 1: Group 2; Part 1: Group 3; Part 1: Group 4; Part 1: Group 5; Part 1: Group 6; Part 2: Group 10; Part 2: Group 11; Part 2: Group 7; Part 2: Group 8; Part 2: Group 9

Itraconazole DRUG

Oral Capsule

Part 4: Itraconazole

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead
• Calico Life Sciences LLC: collaborator

Study Sites (1)

Acpru /Id# 270532

Grayslake, Illinois, 60030, United States

Location

Related Links

• Related Info

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 6, 2024
• First Posted: November 21, 2024
• Study Start: November 11, 2024
• Primary Completion: January 9, 2026
• Study Completion: January 9, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)