ABBV-701 for Healthy Subjects

Recruiting at 1 trial location

Overseen By ABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Disqualifiers: Cardiovascular, Respiratory, Renal, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

100 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-701 to assess its safety and behavior in the body. Researchers administer different doses of ABBV-701 or a placebo (a harmless pill with no effect) to healthy adults. The trial focuses on understanding the treatment's safety and any possible immune reactions. It suits individuals in good health, without major illnesses or significant allergies. As a Phase 1 trial, participants will be among the first to receive this treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the trial is for healthy participants, it's possible that taking medications could affect eligibility.

Is there any evidence suggesting that ABBV-701 is likely to be safe for humans?

Research into ABBV-701 remains in the early stages, so information on its safety is limited. This trial is a Phase 1 study, primarily aiming to determine if ABBV-701 is safe and well-tolerated by healthy adults. The goal at this stage is to observe the body's response to the treatment and identify any side effects.

Since ABBV-701 has not been approved for any condition, no previous data from other uses exists. Safety information is mostly gathered from this early testing. Participants receive different doses to help researchers determine the safest amount.

Overall, while detailed safety data is not yet available, this phase is crucial to ensure ABBV-701's safety for further testing. Participants in this trial assist researchers in understanding how well the treatment is tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

ABBV-701 is unique because it offers a potentially new approach to treatment with its novel mechanism of action. Unlike current treatments that may focus on broader targets, ABBV-701 is designed to precisely target specific pathways, potentially leading to more effective outcomes with fewer side effects. Researchers are excited about ABBV-701 because it could offer a more streamlined treatment option, potentially reducing the time needed to see therapeutic results compared to existing standards of care. This specificity and efficiency make ABBV-701 a promising candidate in the landscape of emerging treatments.

What evidence suggests that ABBV-701 could be effective?

Research has shown that ABBV-701 is a monoclonal antibody designed to target a protein called TL1A. This protein is associated with inflammatory bowel disease (IBD), suggesting that ABBV-701 might help treat these conditions. In this trial, participants will receive a single dose of either ABBV-701 or a placebo to assess its safety and how the body processes it, rather than its effectiveness in patients. Since the trial involves healthy individuals, the primary goal is to ensure that any side effects are manageable. By targeting TL1A, ABBV-701 may reduce inflammation in IBD, but further research is needed to confirm its effectiveness. ^{1 2 6 7 8}

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 from Western and Asian backgrounds. Specific eligibility criteria are not detailed, but typically participants must meet certain health standards and not have conditions that could interfere with the study.

Inclusion Criteria

Body Mass Index (BMI) must be ≥ 18.0 to ≤ 32.0 kg/m^2 after rounding to the tenths decimal. BMI is calculated as weight in kg divided by the square of height measured in meters

For Japanese Participants: Participant must be first or second-generation Japanese parentage (both parents of Japanese descent), residing outside of Japan. Participants must be in general good health and maintain a typical Japanese lifestyle, including consuming a typical Japanese diet. For Han Chinese Participants: Participant must be first or second-generation Han Chinese of full Chinese parentage (both parents of Han Chinese descent), residing outside of China. Participants must be in general good health and maintain a typical Chinese lifestyle, including consuming a typical Chinese diet.

My overall health is good based on recent medical exams.

Exclusion Criteria

History of any clinically significant sensitivity or allergy to any medication or food

I don't have any major health issues apart from my cancer.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single ascending subcutaneous dose of ABBV-701 or placebo

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, pharmacokinetics, and immunogenicity after treatment

47 weeks

What Are the Treatments Tested in This Trial?

Interventions

• ABBV-701

Trial Overview The study is testing ABBV-701, a new medication given as a subcutaneous injection. Participants will be randomly assigned to receive either ABBV-701 or a placebo to compare effects on safety, how the body processes it, and if it causes an immune response.

How Is the Trial Designed?

Group I: Part 4: Group 12 ABBV-701 or Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-701 Dose F or placebo.

Group II: Part 4: Group 11 ABBV-701 or Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-701 Dose F or placebo.

Group III: Part 3: Group 9 ABBV-701 or Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-701 Dose E or placebo.

Group IV: Part 3: Group 8 ABBV-701 or Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-701 Dose C or placebo.

Group V: Part 3: Group 10 ABBV-701 or Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-701 Dose F or placebo.

Group VI: Part 2: Group 7 ABBV-701 or Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-701 Dose E or placebo.

Group VII: Part 2: Group 6 ABBV-701 or Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-701 Dose E or placebo.

Group VIII: Part 1: Group 5 ABBV-701 or Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-701 Dose E or placebo.

Group IX: Part 1: Group 4 ABBV-701 or Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-701 Dose D or placebo.

Group X: Part 1: Group 3 ABBV-701 or Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-701 Dose C or placebo.

Group XI: Part 1: Group 2 ABBV-701 or Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-701 Dose B or placebo.

Group XII: Part 1: Group 1 ABBV-701 or Placebo Experimental Treatment 2 Interventions

Participants will receive a single dose of either ABBV-701 Dose A or placebo.

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

Published Research Related to This Trial

Adeno-associated virus (AAV) gene therapies show great potential for treating neuromuscular disorders like spinal muscular atrophy and Duchenne muscular dystrophy, but there have been serious safety concerns, including reports of deaths.

A recent meeting of clinicians and industry representatives highlighted the need for better reporting and monitoring of adverse events associated with AAV therapies to enhance patient safety and improve information sharing across trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

261st ENMC International Workshop: Management of safety issues arising following AAV gene therapy. 17th-19th June 2022, Hoofddorp, The Netherlands. Servais, L., Horton, R., Saade, D., et al.[2023]

A systematic review of adeno-associated virus (AAV) gene therapies highlights their potential efficacy in treating previously untreatable neurological conditions, with an increasing number of clinical trials underway.

However, there are significant safety concerns, including reports of severe adverse reactions and even deaths, emphasizing the need for unified reporting of these events to enhance treatment safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A systematic review of adeno-associated virus gene therapies in neurology: the need for consistent safety monitoring of a promising treatment. Horton, RH., Saade, D., Markati, T., et al.[2022]

Alipogene tiparvovec (Glybera) has been approved in Europe as a significant advancement in gene therapy for treating familial lipoprotein lipase deficiency, marking a milestone in the clinical application of gene therapies.

The review highlights important safety considerations for gene therapies using adeno-associated virus (AAV) vectors, including potential acute and immunological reactions, viral distribution, and risks of DNA integration and carcinogenicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety profile of recombinant adeno-associated viral vectors: focus on alipogene tiparvovec (Glybera®). Salmon, F., Grosios, K., Petry, H.[2014]

Citations

1. abbvieclinicaltrials.com abbvieclinicaltrials.com/study/?id=M25-491

A Study to Evaluate the Safety, Tolerability ... The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous (SC) ABBV-701 in healthy adult

2. withpower.com withpower.com/trial/phase-1-healthy-subjects-hs-2-2025-ef935

ABBV-701 for Healthy Subjects This Phase 1 medical study run by AbbVie is evaluating whether ABBV-701 will have tolerable side effects & efficacy for patients with Healthy Subjects.

3. trialx.com trialx.com/clinical-trials/listings/313020/a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-immunogenicity-of-single-ascending-subcutaneous-doses-of-abbv-701-in-healthy-adult-western-and-asian-participants/

A Study to Evaluate the Safety, Tolerability ... The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous (SC) ABBV-701 in ...

4. pryzm.ozmosi.com pryzm.ozmosi.com/product/34338

ABBV-701 Drug Profile FG-M701 is a fully human monoclonal antibody targeting TL1A, a clinically validated target in IBD. FG-M701 is uniquely engineered with potential ...

5. synapse.patsnap.com synapse.patsnap.com/drug/2e66197a61134c69b2ee7f01bbd9996f

FG-M701 - Drug Targets, Indications, Patents ... ABBV-701 in Healthy Adult Western and Asian Subjects. 100 Clinical Results ... Highlights included new safety and efficacy data from a Phase 1 study of ABBV ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06895343/a-study-to-evaluate-the-safety-tolerability-pharmacokinetics-and-immunogenicity-of-single-ascending-subcutaneous-doses-of-abbv-701-in-healthy-adult-western-and-asian-participants?state=IL&city=Grayslake

A Study to Evaluate the Safety, Tolerability ... The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous (SC) ABBV-701 ...

7. app.trialscreen.org app.trialscreen.org/trials/phase-1-to-evaluate-safety-tolerability-pharmacokinetics-immunogenicity-trial-nct06895343

A study to evaluate the safety and pharmacokinetics ... A Phase 1 study of ABBV-701 in healthy adults. A study to evaluate the safety and pharmacokinetics of an investigational drug called ABBV-701 in healthy adults.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06468228

NCT06468228 | A Study to Assess Disease Activity and ... This study will compare lutikizumab versus placebo for the treatment of adult and adolescent participants with the signs and symptoms of moderate to severe HS.