New drug ABBV-CLS-616 tested for safety in healthy people
NCT ID NCT06698926
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
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110 people
The number who actually took part.
- Started
-
Nov 2024
- Finished
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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
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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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
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