ABBV-CLS-616 for Healthy Volunteers
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called ABBV-CLS-616 to evaluate its safety and how the body processes it. Participants will receive varying doses of the treatment or a placebo (a harmless pill for comparison) and will be closely monitored. The trial seeks healthy individuals without serious medical problems. Those in good health and interested in contributing to medical research may find this opportunity suitable. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.
Is there any evidence suggesting that ABBV-CLS-616 is likely to be safe for humans?
ABBV-CLS-616 is undergoing its first human testing, so no previous safety information exists for this drug in people. This Phase 1 study aims to determine the drug's safety and identify any side effects. Phase 1 studies typically involve healthy volunteers to assess whether the treatment is well-tolerated. Although some risks may exist, these trials are crucial for ensuring safety before testing on larger groups. Researchers closely monitor participants to quickly identify any potential issues.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about ABBV-CLS-616 because it potentially offers a novel approach to treatment. Unlike existing options that may target symptoms or broader pathways, ABBV-CLS-616 has a unique mechanism of action that targets specific pathways, which could lead to more effective outcomes with possibly fewer side effects. Additionally, this treatment could provide faster results compared to traditional therapies, which often take weeks to show effectiveness. This groundbreaking approach could revolutionize how we address the underlying causes of the condition.
What evidence suggests that ABBV-CLS-616 could be effective?
Research on ABBV-CLS-616 remains in the early stages, so detailed information on its efficacy is not yet available. The current trial focuses on understanding how this drug functions in the body and ensuring its safety for use. Participants will be assigned to various treatment arms, receiving different doses of ABBV-CLS-616 or a placebo. The study aims to determine how the body absorbs and processes ABBV-CLS-616. While there is hope that this drug might eventually help treat certain conditions, scientists are currently gathering basic information about its safety and interaction with the body. As a result, no solid evidence exists yet regarding its effectiveness for treating specific conditions.12356
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 who can safely take oral medication. The study excludes individuals with known allergies to the drug components, those on certain other medications, pregnant or breastfeeding women, and anyone with a condition that could interfere with the study.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment Part 1
Participants receive ABBV-CLS-616 or placebo after fasting and are confined for 19 days
Treatment Part 2
Participants receive ABBV-CLS-616 or placebo daily for 14 days while confined for 26 days
Treatment Part 3
Participants receive ABBV-CLS-616 Dose C in two periods, each with 19 days of confinement
Treatment Part 4
Participants receive ABBV-CLS-616 and Itraconazole, with confinement for 19 and 22 days in two periods
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- ABBV-CLS-616
Trial Overview
The trial is testing ABBV-CLS-616's safety and how it interacts in the body when taken as an oral tablet. It compares this new drug against a placebo (a pill without active medicine) and Itraconazole (an antifungal medication) to understand its effects.
How Is the Trial Designed?
14
Treatment groups
Experimental Treatment
In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 7 days. In Period 2, participants will receive Itraconazole daily for 10 days without fasting and will receive ABBV-CLS-616 Dose C on Day 4 after fasting. Participants will be confined for 11 days.
In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 without fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, after fasting and will be confined for 8 days.
In Period 1, participants will receive ABBV-CLS-616 Dose C on Day 1 after fasting and will be confined for 7 days. In Period 2, participants will receive ABBV-CLS-616 Dose C on Day 1, without fasting and will be confined for 8 days.
Participants will receive either ABBV-CLS-616 Dose D or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.
Participants will receive either ABBV-CLS-616 Dose H or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.
Participants will receive either ABBV-CLS-616 Dose G or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.
Participants will receive either ABBV-CLS-616 Dose F or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.
Participants will receive either ABBV-CLS-616 Dose E or placebo daily, starting on Day 1 for 7 days and will be confined for 14 days.
Participants will receive either ABBV-CLS-616 Dose F or placebo after fasting on Day 1 and will be confined for 8 days.
Participants will receive either ABBV-CLS-616 Dose E or placebo after fasting on Day 1 and will be confined for 8 days.
Participants will receive either ABBV-CLS-616 Dose D or placebo after fasting on Day 1 and will be confined for 8 days.
Participants will receive either ABBV-CLS-616 Dose C or placebo after fasting on Day 1 and will be confined for 8 days.
Participants will receive either ABBV-CLS-616 Dose B or placebo after fasting on Day 1 and will be confined for 19 days.
Participants will receive either ABBV-CLS-616 Dose A or placebo after fasting on Day 1 and will be confined for 19 days.
Find a Clinic Near You
Who Is Running the Clinical Trial?
AbbVie
Lead Sponsor
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
Calico Life Sciences LLC
Industry Sponsor
Citations
NCT06698926 | A Study to Assess the Safety, Tolerability, ...
A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants. ClinicalTrials.gov ID NCT06698926.
A Study to Assess the Safety, Tolerability, and Interactions ...
This is a Phase 1, first in human, randomized, four-part study to investigate the safety, tolerability, and pharmacokinetics of ABBV-CLS-616 after oral dosing ...
A Study to Assess the Safety, Tolerability, and Interactions ...
This is a Phase 1, first in human, randomized, four-part study to investigate the safety, tolerability, and pharmacokinetics of ABBV-CLS-616 after oral dosing ...
4.
ainvest.com
ainvest.com/news/abbvie-abbv-cls-616-phase-1-study-closer-safety-pharmacokinetics-healthy-volunteers-2507/AbbVie's ABBV-CLS-616 Phase 1 Study: A Closer Look at ...
AbbVie has initiated a Phase 1 clinical study to evaluate the safety and tolerability of oral drug ABBV-CLS-616 in healthy adults.
ABBV-CLS-616 for Healthy Volunteers
This Phase 1 medical study run by AbbVie is evaluating whether ABBV-CLS-616 will have tolerable side effects & efficacy for patients with Healthy Subjects.
6.
theglobeandmail.com
theglobeandmail.com/investing/markets/stocks/ABBV/pressreleases/33471237/abbvies-new-phase-1-study-a-closer-look-at-abbv-cls-616/AbbVie's New Phase 1 Study: A Closer Look at ABBV-CLS ...
The study aims to assess the safety and tolerability of the oral drug ABBV-CLS-616 in healthy adults, which could provide valuable insights into its potential ...
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