Clinical trial NCT05556226: Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy Participants
Official title: A Phase 1 Study in Healthy Subjects to Evaluate the Relative Bioavailability of ABBV-154
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: ABBV-154
Keywords: ABBV-154
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-09-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess how safe ABBV-154 is and how ABBV-154 moves through the body of adult healthy participants. Adverse Events will be assessed.

ABBV-154 is an investigational drug being developed for potential treatment of immune-mediated inflammatory diseases. Participants are randomly assigned to one of the 2 treatment groups. Approximately 40 adult healthy volunteers will be enrolled in 2 sites in the United States.

All participants will receive ABBV-154 as subcutaneous injections with one of the 2 different formulations.

There may be higher burden for participants in this trial. Participants will be confined for 9 days. Adverse Events and blood tests will be performed.


Eligibility criteria: Inclusion Criteria:

- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the nearest tenth at screening and upon initial confinement.

Exclusion Criteria:

* Participant using any medications, vitamins and/or herbal supplements, within the 2 week period or 5 half-lives (whichever is longer) prior to study drug administration.
* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma), renal, hepatic, gastrointestinal, hematologic, demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease, glaucoma, psychiatric disease or disorder, or any uncontrolled medical illness.
* Prior exposure to similar biologic therapies.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax)
timeFrame: Approximately up to 58 days
measure: Time to Maximum Observed Plasma Concentration (Tmax)
timeFrame: Approximately up to 58 days
measure: Apparent Terminal Phase Elimination Rate Constant (β)
timeFrame: Approximately up to 58 days
measure: The Terminal Phase Elimination Half-Life (t1/2)
timeFrame: Approximately up to 58 days
measure: The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
timeFrame: Approximately up to 58 days
measure: The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
timeFrame: Approximately up to 58 days
measure: Number of Participants with Adverse Events
timeFrame: Approximately up to 72 days
Secondary outcomes:
Other outcomes:
Locations:
city: Grayslake
country: United States
facility: Acpru /Id# 250429
state: Illinois
city: Las Vegas
country: United States
facility: PPD Clinical Research Unit -Las Vegas /ID# 250650
state: Nevada
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: