ABBV-101 for Healthy Adults

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Epilepsy, Cardiac, Respiratory, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 21 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a new oral medication, ABBV-101, behaves in the body with and without food. It aims to understand the impact of a high-fat meal on the medication's absorption and movement through the body. Two groups will alternate between taking the drug on an empty stomach and after eating. Healthy adults with a BMI between 18.0 and 32.0 are suitable candidates. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that ABBV-101 is likely to be safe for humans?

Research has shown that ABBV-101 is undergoing safety testing in various trials. In studies involving individuals with certain blood cancers, some negative health effects have been observed, though these studies primarily involve those with serious health issues.

This trial examines how ABBV-101 works in healthy adults. As a Phase 1 trial, its main goal is to assess the drug's safety and how the body processes it. Phase 1 trials are early tests, so detailed safety information for healthy individuals might not yet be fully available. However, testing in healthy participants suggests a reasonable expectation of safety, as these trials typically start with low doses and gradually increase to assess tolerance. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ABBV-101 because it offers a novel approach by examining the effects of fasting versus non-fasting conditions on the drug's efficacy. Unlike existing treatments that might not consider the timing of administration relative to meals, ABBV-101 could potentially optimize therapeutic outcomes based on this variable. This approach could lead to more personalized and effective treatment plans, enhancing the overall patient experience.

What evidence suggests that ABBV-101 is effective for healthy adults?

Researchers are investigating ABBV-101 to determine its potential in treating B-cell malignancies, which are cancers affecting a type of white blood cell. Early studies have examined the drug's safety and pharmacokinetics, the process by which it moves through the body. These initial studies also explore whether ABBV-101 can reduce disease activity in patients whose cancer has returned or not responded to treatment. While detailed efficacy results are still being collected, the primary goal is to identify the optimal dose and understand the drug's behavior in the body. This ongoing research is crucial to assess whether ABBV-101 can effectively aid those with these challenging conditions. ^{2 3 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This clinical trial is for healthy adults with a Body Mass Index (BMI) between 18.0 and 32.0. Participants should be in good health as determined by medical history, physical exams, vital signs, lab tests, and an ECG.

Inclusion Criteria

My BMI is between 18.0 and 32.0.

I am generally healthy based on recent medical exams.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive ABBV-101 under fasting and non-fasting conditions in two periods

21 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 days

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-101

Trial Overview The study is testing ABBV-101 taken orally to see how food intake, specifically high-fat meals, affects its absorption and movement through the body of healthy participants.

How Is the Trial Designed?

Group I: ABBV-101: Sequence 2 Experimental Treatment 1 Intervention

Participants will receive ABBV-101 under non-fasting conditions in Period 1 and will receive ABBV-101 under fasting conditions in Period 2.

Group II: ABBV-101: Sequence 1 Experimental Treatment 1 Intervention

Participants will receive ABBV-101 under fasting conditions in Period 1 and will receive ABBV-101 under non-fasting conditions in Period 2

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

Citations

1. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-2-2025-cda18

ABBV-101 for Healthy Adults · Info for Participants Participants will receive ABBV-101 under fasting conditions in Period 1 and will receive ABBV-101 under non-fasting conditions in Period 2. Find a Clinic ...

2. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M23-647

Study to Evaluate Adverse Events, Change in Disease ... Study to evaluate adverse events, change in disease activity, and how oral ABBV-101 moves through the body in adult participants with B-cell malignancies.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05960240

NCT05960240 | Safety, Tolerability, PK & PD of AB-101 ... Parts 1 and 2 will be a Phase 1a SAD/MAD of AB-101 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-101 in non-cirrhotic ...

4. cancer.gov cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-04295

Study to Evaluate Adverse Events, Change in Disease ... The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) ...

5. clinicaltrials.stanford.edu clinicaltrials.stanford.edu/trials/s/NCT05753501.html

Study to Evaluate Adverse Events, Change in Disease Activity ... The purpose of this study is to assess the safety, pharmacokinetics, and preliminary efficacy of ABBV-101 in adult participants in relapsed or refractory (R/R) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06887010?aggFilters=phase%3A0+1+2+3+4%2Cstatus%3Anot+rec+act+enr%2CstudyType%3Aint&primComp=2020-01-01_&lastUpdPost=2024-11-08_

A Study to Assess How Food Affects the Movement of Oral ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

7. lymphoma-action.org.uk lymphoma-action.org.uk/trial/abbv-101-phase-1-trial-abbv-101-people-relapsed-or-refractory-b-cell-lymphomas

A phase 1 trial of ABBV-101 in people with relapsed or ... The aim of this trial is to assess how safe and effective the medication ABBV-101 is in adults with relapsed or refractory B-cell lymphomas. It will also ...

8. delta.larvol.com delta.larvol.com/Products/?ProductId=47ab0441-ec51-4238-b8f0-c600e7d3dbc7

ABBV-101 / AbbVie Adverse events • Enrollment change • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • ...