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ABBV-CLS-616 for Healthy Volunteers

Overseen ByABBVIE CALL CENTER

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Recruiting

Sponsor: AbbVie

Disqualifiers: Ocular disease, Neurological epilepsy, Cardiac, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

This trial is for healthy adults who can safely take oral medication. The study excludes individuals with known allergies to the drug components, those on certain other medications, pregnant or breastfeeding women, and anyone with a condition that could interfere with the study.

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 abnormal PT/aPTT/INR values at screening

I am in good health overall, as confirmed by various medical exams.

Exclusion Criteria

Evidence of conditions that might preclude the subject from undergoing a lumbar puncture

I do not have any major health issues apart from mild childhood asthma.

I have an active or recurring eye condition.

See 3 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part 1

Participants receive ABBV-CLS-616 or placebo after fasting and are confined for 19 days

19 days

Treatment Part 2

Participants receive ABBV-CLS-616 or placebo daily for 14 days while confined for 26 days

26 days

Treatment Part 3

Participants receive ABBV-CLS-616 Dose C in two periods, each with 19 days of confinement

38 days

Treatment Part 4

Participants receive ABBV-CLS-616 and Itraconazole, with confinement for 19 and 22 days in two periods

41 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

ABBV-CLS-616 (Cancer Vaccine)

Trial OverviewThe trial is testing ABBV-CLS-616's safety and how it interacts in the body when taken as an oral tablet. It compares this new drug against a placebo (a pill without active medicine) and Itraconazole (an antifungal medication) to understand its effects.

Participant Groups

14Treatment groups

Experimental Treatment

Group I: Part 4: ItraconazoleExperimental Treatment2 Interventions

In Period 1, Participants will be confined for 19 days and receive ABBV-CLS-616 Dose C on Day 1, without fasting. In Period 2, participants will be confined for 22 days and receive ABBV-CLS-616 Dose C on Day 4 without fasting. Participants will also receive Itraconazole daily for 21 days.

Group II: Part 3: Sequence 2Experimental Treatment1 Intervention

In Period 1, Participants will be confined for 19 days and receive ABBV-CLS-616 Dose C on Day 1, without fasting. In Period 2, participants will be confined for 19 days and receive ABBV-CLS-616 Dose C on Day 1 after fasting.

Group III: Part 3: Sequence 1Experimental Treatment1 Intervention

In Period 1, participants will be confined for 19 days and receive ABBV-CLS-616 Dose C on Day 1 after fasting. In Period 2, Participants will be confined for 19 days and receive ABBV-CLS-616 Dose C on Day 1, without fasting.

Group IV: Part 2: Group 9Experimental Treatment2 Interventions

Participants will receive either ABBV-CLS-616 Dose D or placebo daily, starting on Day 1, for 14 days while confined for 26 days.

Group V: Part 2: Group 8Experimental Treatment2 Interventions

Participants will receive either ABBV-CLS-616 Dose H or placebo daily, starting on Day 1, for 14 days while confined for 26 days.

Group VI: Part 2: Group 7Experimental Treatment2 Interventions

Participants will receive either ABBV-CLS-616 Dose G or placebo daily, starting on Day 1, for 14 days while confined for 26 days.

Group VII: Part 2: Group 11Experimental Treatment2 Interventions

Participants will receive either ABBV-CLS-616 Dose F or placebo daily, starting on Day 1, for 14 days while confined for 26 days.

Group VIII: Part 2: Group 10Experimental Treatment2 Interventions

Participants will receive either ABBV-CLS-616 Dose E or placebo daily, starting on Day 1, for 14 days while confined for 26 days.

Group IX: Part 1: Group 6Experimental Treatment2 Interventions

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

Group X: Part 1: Group 5Experimental Treatment2 Interventions

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

Group XI: Part 1: Group 4Experimental Treatment2 Interventions

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

Group XII: Part 1: Group 3Experimental Treatment2 Interventions

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

Group XIII: Part 1: Group 2Experimental Treatment2 Interventions

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

Group XIV: Part 1: Group 1Experimental Treatment2 Interventions

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

Find a Clinic Near You

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments