ABBV-CLS-616 for Healthy Volunteers

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Ocular disease, Neurological epilepsy, Cardiac, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

112 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called ABBV-CLS-616 to evaluate its safety and how the body processes it. Participants will receive varying doses of the treatment or a placebo (a harmless pill for comparison) and will be closely monitored. The trial seeks healthy individuals without serious medical problems. Those in good health and interested in contributing to medical research may find this opportunity suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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.

Is there any evidence suggesting that ABBV-CLS-616 is likely to be safe for humans?

ABBV-CLS-616 is undergoing its first human testing, so no previous safety information exists for this drug in people. This Phase 1 study aims to determine the drug's safety and identify any side effects. Phase 1 studies typically involve healthy volunteers to assess whether the treatment is well-tolerated. Although some risks may exist, these trials are crucial for ensuring safety before testing on larger groups. Researchers closely monitor participants to quickly identify any potential issues. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about ABBV-CLS-616 because it potentially offers a novel approach to treatment. Unlike existing options that may target symptoms or broader pathways, ABBV-CLS-616 has a unique mechanism of action that targets specific pathways, which could lead to more effective outcomes with possibly fewer side effects. Additionally, this treatment could provide faster results compared to traditional therapies, which often take weeks to show effectiveness. This groundbreaking approach could revolutionize how we address the underlying causes of the condition.

What evidence suggests that ABBV-CLS-616 could be effective?

Research on ABBV-CLS-616 remains in the early stages, so detailed information on its efficacy is not yet available. The current trial focuses on understanding how this drug functions in the body and ensuring its safety for use. Participants will be assigned to various treatment arms, receiving different doses of ABBV-CLS-616 or a placebo. The study aims to determine how the body absorbs and processes ABBV-CLS-616. While there is hope that this drug might eventually help treat certain conditions, scientists are currently gathering basic information about its safety and interaction with the body. As a result, no solid evidence exists yet regarding its effectiveness for treating specific conditions. ^{1 2 3 5 6}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

History of lumbar puncture and/or collection of cerebrospinal fluid within 30 days prior to Screening

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-CLS-616

Trial Overview The 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.

How Is the Trial Designed?

Group I: Part 4: Itraconazole Experimental Treatment 2 Interventions

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 II: Part 3: Sequence 2 Experimental Treatment 1 Intervention

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 III: Part 3: Sequence 1 Experimental Treatment 1 Intervention

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 IV: Part 2: Group 9 Experimental Treatment 2 Interventions

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 V: Part 2: Group 8 Experimental Treatment 2 Interventions

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 VI: Part 2: Group 7 Experimental Treatment 2 Interventions

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 VII: Part 2: Group 11 Experimental Treatment 2 Interventions

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 VIII: Part 2: Group 10 Experimental Treatment 2 Interventions

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 IX: Part 1: Group 6 Experimental Treatment 2 Interventions

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

Group X: Part 1: Group 5 Experimental Treatment 2 Interventions

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

Group XI: Part 1: Group 4 Experimental Treatment 2 Interventions

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

Group XII: Part 1: Group 3 Experimental Treatment 2 Interventions

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

Group XIII: Part 1: Group 2 Experimental Treatment 2 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 1 Experimental Treatment 2 Interventions

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

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

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Calico Life Sciences LLC

Industry Sponsor

Trials

11

Recruited

960+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06698926

NCT06698926 | A Study to Assess the Safety, Tolerability, ... A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants. ClinicalTrials.gov ID NCT06698926.

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M25-206

A Study to Assess the Safety, Tolerability, and Interactions ... 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 ...

3. trialx.com trialx.com/clinical-trials/listings/321282/a-study-to-assess-the-safety-tolerability-and-interactions-of-abbv-cls-616-oral-tablets-in-healthy-adult-participants/

A Study to Assess the Safety, Tolerability, and Interactions ... 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 ...

4. ainvest.com ainvest.com/news/abbvie-abbv-cls-616-phase-1-study-closer-safety-pharmacokinetics-healthy-volunteers-2507/

AbbVie's ABBV-CLS-616 Phase 1 Study: A Closer Look at ... AbbVie has initiated a Phase 1 clinical study to evaluate the safety and tolerability of oral drug ABBV-CLS-616 in healthy adults.

5. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-10-2024-7babf

ABBV-CLS-616 for Healthy Volunteers This Phase 1 medical study run by AbbVie is evaluating whether ABBV-CLS-616 will have tolerable side effects & efficacy for patients with Healthy Subjects.

6. theglobeandmail.com theglobeandmail.com/investing/markets/stocks/ABBV/pressreleases/33471237/abbvies-new-phase-1-study-a-closer-look-at-abbv-cls-616/

AbbVie's New Phase 1 Study: A Closer Look at ABBV-CLS ... The study aims to assess the safety and tolerability of the oral drug ABBV-CLS-616 in healthy adults, which could provide valuable insights into its potential ...