40 Participants Needed

ABBV-277 for Safety in Healthy Adults

AC
Overseen ByABBVIE CALL CENTER
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and metabolism of a new treatment called ABBV-277 in healthy adults. Participants will receive varying doses of ABBV-277 or a placebo to observe their reactions over time. The trial seeks healthy individuals with stable weight and no significant medical issues, such as heart or liver problems. As an early-stage, Phase 1 trial, the focus is on ensuring the treatment's safety. Participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any medications, vitamins, or herbal supplements at least 14 days before the study drug is given, or longer if the medication stays in your system for a while.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that ABBV-277 is a new drug undergoing safety testing in healthy adults. This study marks the first time the drug has been tested in humans. Due to its early stage, limited information exists on human responses. The trial aims to assess the safety of ABBV-277 and how the body processes it.

Researchers closely monitor for any side effects or issues during these early tests. Since ABBV-277 lacks approval for other uses, its safety in humans remains under study. Participants receive varying doses to observe their reactions over time, helping to determine the safest way to use the drug in the future.12345

Why are researchers excited about this trial's treatment?

ABBV-277 is unique because it is a new investigational treatment being explored for its safety in healthy adults. Unlike existing treatments, which often focus on traditional therapeutic pathways, ABBV-277 could potentially offer a novel mechanism of action, though the details of this mechanism aren't specified here. Researchers are excited about ABBV-277 because it is being tested across multiple dosage levels to closely monitor its safety and effectiveness, which indicates a thorough approach to understanding its potential benefits and risks. This careful examination could lead to new insights and possibly a new class of treatments in the future.

What evidence suggests that this trial's treatments could be effective?

ABBV-277 is a new treatment under investigation to determine its effects in the body and any potential side effects. This trial includes various treatment arms where participants receive different doses of ABBV-277 or a placebo. The primary focus is to ensure its safety for human use. Specific information on its effectiveness for any particular health condition is not yet available. Researchers are studying the treatment in healthy adults to gather preliminary safety data, with more details expected from future research. The goal is to understand how the body processes the drug and to identify any unwanted reactions.12345

Who Is on the Research Team?

AI

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for healthy adults with a BMI between 18.0 and 32.0, weighing at least 35 kg, and in good health as determined by medical history, physical exam, vital signs, lab tests, neurological exam, and ECG.

Inclusion Criteria

My BMI is between 18.0 and 32.0.
I am generally healthy based on recent medical exams.
I weigh at least 35 kg.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single dose of ABBV-277 or placebo and are monitored for pharmacokinetics and safety

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and pharmacokinetics over an extended period

196 days
Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

  • ABBV-277
Trial Overview The study is testing ABBV-277's safety and how the body absorbs it after one dose compared to a placebo (a substance with no active drug). Participants will be randomly assigned to receive either ABBV-277 or the placebo.
How Is the Trial Designed?
10Treatment groups
Experimental Treatment
Group I: Group 5: PlaceboExperimental Treatment1 Intervention
Group II: Group 5: ABBV-277-Dose EExperimental Treatment1 Intervention
Group III: Group 4: PlaceboExperimental Treatment1 Intervention
Group IV: Group 4: ABBV-277-Dose DExperimental Treatment1 Intervention
Group V: Group 3: PlaceboExperimental Treatment1 Intervention
Group VI: Group 3: ABBV-277-Dose CExperimental Treatment1 Intervention
Group VII: Group 2: PlaceboExperimental Treatment1 Intervention
Group VIII: Group 2: ABBV-277-Dose BExperimental Treatment1 Intervention
Group IX: Group 1: PlaceboExperimental Treatment1 Intervention
Group X: Group 1: ABBV-277-Dose AExperimental Treatment1 Intervention

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

Citations

NCT07136103 | A Study to Evaluate the Safety, Tolerability ...Also called a data safety and ... Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Subjects.
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics ...The objective of this study is to evaluate the safety, tolerability, immunogenicity and pharmacokinetics (PK ) properties following a single dose of ABBV-277 in ...
AbbVie's ABBV-277 Study: A New Frontier in Drug Safety ...' The study aims to assess the safety and pharmacokinetic properties of ABBV-277, a new drug candidate, in healthy adults. This research is ...
ABBV-277 for Safety in Healthy AdultsThis trial is for healthy adults with a BMI between 18.0 and 32.0, weighing at least 35 kg, and in good health as determined by medical history, physical exam, ...
Clinical Trial: A Study to Evaluate the Safety, Tolerability, ...Clinical Trial: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants.
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