Study to Assess Adverse Events and Compare How Two Subcutaneous ABBV-154 Injection Formulations Move Through the Body of Adult Healthy Participants
- Conditions
- ABBV-154
- Interventions
- Drug: ABBV-154 Dose Formulation ADrug: ABBV-154 Dose Formulation B
- Registration Number
- NCT05556226
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Body Mass Index (BMI) is ≥ 18.0 to ≤ 29.9 kg/m2 after rounding to the nearest tenth at screening and upon initial confinement.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description ABBV-154 Dose A ABBV-154 Dose Formulation A Participants will receive subcutaneous dose of ABBV-154 Dose Formulation A. ABBV-154 Dose B ABBV-154 Dose Formulation B Participants will receive subcutaneous dose of ABBV-154 Dose Formulation B.
- Primary Outcome Measures
Name Time Method The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞) Approximately up to 58 days The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Infinity (AUC∞)
Number of Participants with Adverse Events Approximately up to 72 days An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study.
Time to Maximum Observed Plasma Concentration (Tmax) Approximately up to 58 days Time to Maximum Observed Plasma Concentration (Tmax)
Apparent Terminal Phase Elimination Rate Constant (β) Approximately up to 58 days Apparent Terminal Phase Elimination Rate Constant (β)
The Terminal Phase Elimination Half-Life (t1/2) Approximately up to 58 days The Terminal Phase Elimination Half-Life (t1/2)
Maximum Observed Plasma Concentration (Cmax) Approximately up to 58 days Maximum Observed Plasma Concentration (Cmax)
The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt) Approximately up to 58 days The Area Under the Plasma Concentration-Time Curve (AUC) from Time 0 to Time of the Last Measurable Concentration (AUCt)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Acpru /Id# 250429
🇺🇸Grayslake, Illinois, United States
PPD Clinical Research Unit -Las Vegas /ID# 250650
🇺🇸Las Vegas, Nevada, United States