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

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Healthy Volunteer

Treatments: Drug: Placebo; Drug: ABBV-8736

Study type: Interventional

Funder types: Industry

Identifiers

NCT07141199

M25-918

Details and patient eligibility

About

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.

Enrollment: 24 estimated patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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24 participants in 4 patient groups, including a placebo group

Group 1: Dose A of ABBV-8736

Experimental group

Description:

Participants will receive intravenous (IV) ABBV-8736 dose A every 2 weeks for a total of 3 doses.

Treatment:

Drug: ABBV-8736

Group 1: Dose A of ABBV-8736 Placebo

Placebo Comparator group

Description:

Participants will receive IV ABBV-8736 placebo dose A every 2 weeks for a total of 3 doses.

Treatment:

Drug: Placebo

Group 2: Dose B of ABBV-8736

Experimental group

Description:

Participants will receive IV ABBV-8736 dose B every 2 weeks for a total of 3 doses.

Treatment:

Drug: ABBV-8736

Group 2: Dose B of ABBV-8736 Placebo

Placebo Comparator group

Description:

Participants will receive IV ABBV-8736 placebo dose B every 2 weeks for a total of 3 doses.

Treatment:

Drug: Placebo