58 Participants Needed

ABBV-701 for Healthy Subjects

AC
Overseen ByABBVIE CALL CENTER
Age: 18 - 65
Sex: Any
Trial Phase: Phase 1
Sponsor: AbbVie
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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.

What safety data exists for ABBV-701 or similar treatments?

Adeno-associated virus (AAV) gene therapies, which include treatments like ABBV-701, have shown promise but also raised safety concerns. Some studies report no major safety issues, while others note serious adverse events, including deaths, highlighting the need for consistent safety monitoring.12345

What is the purpose of this trial?

The main objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity of subcutaneous (SC) ABBV-701 in healthy adult western and Asian participants.

Research Team

AI

ABBVIE INC.

Principal Investigator

AbbVie

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
7Treatment groups
Experimental Treatment
Group I: Part 2: Group 7 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose E or placebo.
Group II: Part 2: Group 6 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose E or placebo.
Group III: Part 1: Group 5 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose E or placebo.
Group IV: Part 1: Group 4 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose D or placebo.
Group V: Part 1: Group 3 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose C or placebo.
Group VI: Part 1: Group 2 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose B or placebo.
Group VII: Part 1: Group 1 ABBV-701 or PlaceboExperimental Treatment2 Interventions
Participants will receive a single dose of either ABBV-701 Dose A or placebo.

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
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 profile image

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Findings from Research

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

References

Safety profile of recombinant adeno-associated viral vectors: focus on alipogene tiparvovec (Glybera®). [2014]
Long-Term Follow-Up of the First in Human Intravascular Delivery of AAV for Gene Transfer: AAV2-hFIX16 for Severe Hemophilia B. [2021]
261st ENMC International Workshop: Management of safety issues arising following AAV gene therapy. 17th-19th June 2022, Hoofddorp, The Netherlands. [2023]
A systematic review of adeno-associated virus gene therapies in neurology: the need for consistent safety monitoring of a promising treatment. [2022]
The National Gene Vector Biorepository: Eleven Years of Providing Resources to the Gene Therapy Community. [2021]
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