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Sequence 3 for Healthy Subjects

Phase 1

Recruiting

Research Sponsored by Calico Life Sciences LLC

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 24 hours

Awards & highlights

Study Summary

This trial will test the impact of ABBV-CLS-7262 on heart function in healthy adults using a randomized and controlled study design.

Who is the study for?

This trial is for healthy adults. Participants must meet certain health standards, but specific inclusion and exclusion criteria are not listed here.Check my eligibility

What is being tested?

The study tests the effects of ABBV-CLS-7262 on heart rhythm compared to Moxifloxacin (an antibiotic known to affect heart rhythm) and a placebo in a controlled environment where participants receive each treatment in turns.See study design

What are the potential side effects?

Potential side effects may include changes in heart rhythm or other cardiac-related issues due to the nature of the study, although specifics are not provided.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

To evaluate the effect of ABBV-CLS-7262 on the QTc interval in healthy adult subjects

Secondary outcome measures

To evaluate the effect of ABBV-CLS-7262 on T-wave morphology

To evaluate the effects of ABBV-CLS-7262 on change in electrocardiogram (ECG) parameters

To evaluate the sensitivity of QTc measurement using moxifloxacin

Trial Design

4Treatment groups

Experimental Treatment

Group I: Sequence 4Experimental Treatment3 Interventions

Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet

Group II: Sequence 3Experimental Treatment3 Interventions

Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet

Group III: Sequence 2Experimental Treatment3 Interventions

Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet

Group IV: Sequence 1Experimental Treatment3 Interventions

Subjects will receive ABBV-CLS-7262 dose 1, ABBV-CLS-7262 dose 2, placebo, or moxifloxacin 400 mg tablet

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

ABBV-CLS-7262

2023

Completed Phase 1

~30

Placebo

1995

Completed Phase 3

~2670

Moxifloxacin 400mg

2012

Completed Phase 1

~830

Do I qualify?Apply below to find out

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Calico Life Sciences LLCLead Sponsor

8 Previous Clinical Trials

886 Total Patients Enrolled

AbbVieIndustry Sponsor

958 Previous Clinical Trials

502,318 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for patients to participate in this clinical trial?

"Information on clinicaltrials.gov states that recruitment for this trial is presently closed. This specific study was initially listed on March 1, 2024 and most recently modified on March 12, 2024. Despite the current inactivity of this trial, it's worth noting that there are approximately eight hundred thirty other trials actively seeking participants."

Answered by AI

What is the level of safety associated with Sequence 4 for individuals?

"The safety assessment of Sequence 4 by our team at Power is rated as 1 on the scale. This rating aligns with it being a Phase 1 trial, indicating that there exists minimal data supporting both safety and effectiveness."

Answered by AI

Which specific criteria must individuals meet in order to qualify for participation in this research?

"To be eligible for participation, individuals must meet the criteria of being in good health and aged between 18 to 55 years. The study has a capacity for enrolling up to 72 participants."

Answered by AI

Does this medical study allow participation for individuals older than 45 years?

"Participants entering this research study must be within the age bracket of 18 to 55. Notably, there are a total of 68 trials dedicated to individuals younger than 18 years old and another 379 studies tailored for those above the age of 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects

2024. "A Thorough QT Study of ABBV-CLS-7262 in Healthy Subjects". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06310876.

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