ABBV-547 for Healthy Subjects

Recruiting at 1 trial location

Overseen ByABBVIE CALL CENTER

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must not be taking: Herbal supplements, Biologics

Disqualifiers: Allergies, others

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 tests a new treatment called ABBV-547 to evaluate its safety, effectiveness, and tolerability in healthy adults in the United States and Japan. The study consists of two parts, with participants receiving different doses of ABBV-547 or a placebo (a harmless, inactive substance). Participants will regularly visit a hospital or clinic for health checks, blood tests, and to complete questionnaires. To join, individuals should be in general good health and, for Part 2, must have stopped using specific light therapy treatments a few weeks before starting the trial. As a Phase 1 trial, this research focuses on understanding how ABBV-547 works in people, offering participants the opportunity to be among the first to receive this new treatment.

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. However, if you are in Part 2, you must stop using herbal supplements two weeks before the study treatment.

Is there any evidence suggesting that ABBV-547 is likely to be safe for humans?

Research has shown that ABBV-547 is under study to determine its safety for people. This early-stage study examines how the body processes the drug and monitors for any side effects. Early studies like this aim to ensure the treatment is safe and tolerable at various doses. Although specific safety data on ABBV-547 is not yet available, the focus on safety is paramount in these initial trials. Researchers will closely monitor participants for any side effects, and regular medical check-ups and tests will track how well they tolerate the treatment.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Researchers are excited about ABBV-547 because it offers a new approach to treatment by potentially targeting the underlying mechanisms of a condition more effectively than current options. Unlike standard treatments that might focus on symptom relief, ABBV-547 is being explored for its unique mechanism of action, which could provide a more direct impact on the root cause of the condition. Additionally, ABBV-547 may offer improved delivery methods or formulations that enhance its effectiveness or reduce side effects, setting it apart from existing therapies.

What evidence suggests that ABBV-547 could be effective?

Research on ABBV-547 is just starting, so little information exists about its effectiveness in people. In this trial, participants will join different groups to receive either ABBV-547 or a placebo. The researchers aim to study ABBV-547 to learn about its safety and effectiveness. The goal is to understand how this drug acts in the body and its potential effects. Although definite results are not yet available, this study is crucial to determine if ABBV-547 could become a useful treatment in the future. Early tests help researchers decide if it's safe to test in larger groups later on.¹ ² ³ ⁴ ⁶

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 with a BMI between 18.0 and 29.9 in Part 1, and those who haven't used phototherapy recently in Part 2. Participants must be generally healthy as determined by medical history, physical exams, vital signs, lab tests, and an ECG.

Inclusion Criteria

My BMI is between 18.0 and 29.9.

I stopped using phototherapy 2 weeks ago and PUVA 4 weeks ago.

I am in good health overall, as confirmed by recent medical exams.

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-547 or placebo and attend regular visits for assessments

1 day

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including medical assessments, blood tests, and questionnaires

Up to 52 weeks

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

ABBV-547

Trial Overview

The study is testing the safety and tolerability of ABBV-547 injections compared to placebo. It's divided into two parts; each part has participants randomly assigned to receive different doses of ABBV-547 or placebo at a chance specified for each part.