A Study to Assess Adverse Events and How Single and Multiple Ascending Doses of ABBV-903 Move Through the Body in 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: 36 days

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new drug called ABBV-903 to see if it is safe and well-tolerated by healthy adults. Researchers want to know how the drug behaves in the body when taken in different doses.

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. However, since the study involves healthy volunteers, it might be expected that participants are not on any regular medications.

What data supports the effectiveness of the drug ABBV-903?

The research indicates that treatments targeting CD33, like ABBV-903, have shown effectiveness in eliminating acute myeloid leukemia cells by engaging the immune system to attack cancer cells. Similar treatments have demonstrated strong anti-leukemic effects in laboratory settings, suggesting potential effectiveness for ABBV-903. ^{1 2 3 4 5}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

Inclusion Criteria

You must satisfactorily meet all medical requirements, including a comprehensive medical history evaluation, physical examination, vital signs assessment, laboratory analysis and 12-lead ECG.

Your body mass index (BMI) falls between 18.0 to 32 kg/m2.

Exclusion Criteria

You have a history of certain types of cancer, except for non-spreading skin cancers or early-stage cervical cancer.

You have a history of epilepsy or any significant health conditions affecting your heart, breathing, kidneys, liver, digestive system, blood, or mental health. You also have any ongoing medical conditions that are not under control.

History of any clinically significant illness/infection/major febrile illness, hospitalization, or any surgical procedure within 30 days prior to the first dose of study drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive single and multiple ascending doses of ABBV-903 or placebo

36 days

Follow-up

Participants are monitored for safety and effectiveness after treatment

30 days

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-903

How Is the Trial Designed?

Group I: Part 3, Sequence 2 Experimental Treatment 2 Interventions

Participants in Part 3 will follow Sequence 2.

Group II: Part 3, Sequence 1 Experimental Treatment 2 Interventions

Participants in Part 3 will follow Sequence 1.

Group III: Part 2, Placebo Experimental Treatment 1 Intervention

Participants will receive multiple ascending doses of placebo in Part 2.

Group IV: Part 2, ABBV-903 Experimental Treatment 1 Intervention

Participants will receive multiple ascending doses of ABBV-903 in Part 2.

Group V: Part 1, Placebo Experimental Treatment 1 Intervention

Participants will receive a single ascending dose of placebo in Part 1.

Group VI: Part 1, ABBV-903 Experimental Treatment 1 Intervention

Participants will receive a single ascending dose of ABBV-903 in Part 1.

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. United States pubmed.ncbi.nlm.nih.gov

Effective elimination of acute myeloid leukemic cells by recombinant bispecific antibody derivatives directed against CD33 and CD16. [2012]

2. China pubmed.ncbi.nlm.nih.gov

[Construction and expression of anti-CD3/anti-prostate-cancer bispecific single-chain antibody]. [2017]

3. United States pubmed.ncbi.nlm.nih.gov

Murine and humanized constructs of monoclonal antibody M195 (anti-CD33) for the therapy of acute myelogenous leukemia. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Direct effect of bispecific anti-CD33 x anti-CD64 antibody on proliferation and signaling in myeloid cells. [2022]

5. England pubmed.ncbi.nlm.nih.gov

A recombinant trispecific single-chain Fv derivative directed against CD123 and CD33 mediates effective elimination of acute myeloid leukaemia cells by dual targeting. [2021]