A Study to Evaluate Adverse Events, How the Drug is Tolerated, and How the Drug Moves Through theā¦ (NCT07141199) | Clinical Trial Compass
CompletedPhase 1
A Study to Evaluate Adverse Events, How the Drug is Tolerated, and How the Drug Moves Through the Body of Intravenous Infusions of ABBV-8736 in Adult Healthy Volunteers
United States24 participantsStarted 2025-09-02
Plain-language summary
The objective of this study is to assess the safety, tolerability, pharmacokinetics, and immunogenicity following multiple intravenous (IV) ascending doses of ABBV-8736 in healthy adult participants.
Who can participate
Age range18 Years ā 55 Years
SexALL
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Inclusion Criteria:
* Body mass index (BMI) is \>= 18.0 to \<= 32.0 kg/m\^2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.
Exclusion Criteria:
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of any clinically significant sensitivity or allergy to any medication or food.
* Prior exposure to a TREM1 agent.
What they're measuring
1
Number of Participants with Adverse Events (AEs)
Timeframe: Up to Approximately 113 Days
2
Maximum Observed Concentration (Cmax) of ABBV-8736
Timeframe: Up to Approximately 113 Days
3
Time to Cmax (Tmax) of ABBV-8736
Timeframe: Up to Approximately 113 Days
4
Area under the plasma concentration-time curve from time 0 until the last measurable concentration (AUCtau) of ABBV-8736
Timeframe: Up to Approximately 113 Days
5
Observed plasma concentration at the end of a dosing interval (Ctrough) of ABBV-8736
Timeframe: Up to Approximately 113 Days
6
Apparent Terminal Phase Elimination Rate Constant (Ī²) of ABBV-8736
Timeframe: Up to Approximately 113 Days
7
Terminal Phase Elimination Half-Life (t1/2) of ABBV-8736