A Study to Assess the Safety, Tolerability, and Interactions of ABBV-CLS-616 Oral Tablets in Healthy Adult Participants

Launched by ABBVIE · Nov 19, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medicine called ABBV-CLS-616 to see if it is safe and how well it is tolerated when taken as a tablet by healthy adults. The trial is in the early Phase 1 stage, which means it is one of the first times this drug is being tested in people. The researchers want to learn how the drug moves through the body and if there are any side effects. The study is currently looking for participants aged 18 to 65 who are in good health, with specific criteria regarding blood tests and medical history to ensure safety during the trial.

If you choose to participate, you will undergo health screenings, including physical exams and lab tests, to make sure you qualify. Participants can expect to take the medication and then be monitored closely for any reactions or side effects. It’s important to note that certain medical conditions or recent procedures may prevent someone from joining, so it’s best to discuss any health concerns with the study team. Overall, this trial aims to provide valuable information about ABBV-CLS-616, which could help in the development of new treatments in the future.

Gender

ALL

Eligibility criteria

• 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.