Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

New drug ABBV-CLS-616 tested for safety in healthy people

NCT ID NCT06698926

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested the safety and how the body processes a new drug called ABBV-CLS-616. It involved 110 healthy volunteers who took the drug or a placebo. The main goal was to check for side effects and understand how the drug moves through the body.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ABBV-CLS-616

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

110 people

The number who actually took part.

Started

Nov 2024

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Part 2 only: Participant must have normal platelet count at screening and upon initial confinement. * Part 2 only: Participant must not have known or suspected coagulopathy, or prothrombin time (PT)/activated partial thromboplastin time (aPTT)/international normalized ratio (INR) values outside of normal range at screening. * A condition of general good health, based upon the results of a medical history, physical examination, vital signs, neurological examination, ophthalmic examination (Part 2 only) laboratory profile and a 12-lead Electrocardiogram. Exclusion Criteria: * Part 2 only: Clinically significant active or recurrent ocular disease. * Part 2 only: History of lumbar puncture and/or collection of cerebrospinal fluid within 30 days prior to Screening. * Part 2 only: History of current condition of chronic lower back pain. * Evidence of conditions that might preclude the subject from undergoing a lumbar puncture. * History of clinically significant neurological epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, coagulopathy, or any uncontrolled medical illness. * History of suicidal ideation within one year prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia Suicide Severity Rating Scale completed at Screening, or any history of suicide attempts within the last two years.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Healthy volunteer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Acpru /Id# 270532

    Grayslake, Illinois, 60030, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.