A Study to Assess the Adverse Events of Intramuscular Injections of AGN-151586 and OnabotulinumtoxinA in Adult Participants for the Change of Glabellar Lines (GL)
A Phase 1 Study to Evaluate the Safety and Efficacy of Co-administration of AGN-151586 and BOTOX® in Subjects for Treatment of Glabellar Lines (GL)
1 other identifier
interventional
132
1 country
8
Brief Summary
The objective of this Phase 1 study is to assess the safety and efficacy of single treatment of AGN-151586 and of OnabotulinumtoxinA in the glabellar complex of participants with moderate to severe glabellar lines (GL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Feb 2025
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 14, 2025
CompletedStudy Start
First participant enrolled
February 18, 2025
CompletedFirst Posted
Study publicly available on registry
February 19, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2025
CompletedNovember 17, 2025
November 1, 2025
9 months
February 14, 2025
November 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with Adverse Events (AEs)
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Up to approximately 10.4 months
Number of Participants with the Presence of Binding and Neutralizing Antidrug Antibodies to AGN-151586 and/or OnabotulinumtoxinA
Samples collected from participants treated with AGN-151586 and OnabotulinumtoxinA will be analyzed for antibodies against both AGN-151586 and OnabotulinumtoxinA.
Up to approximately 10.4 months
Study Arms (5)
Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA
EXPERIMENTALParticipants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.
Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA
EXPERIMENTALParticipants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.
Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA
EXPERIMENTALParticipants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.
Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA
EXPERIMENTALParticipants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.
Cohort 3: Placebo and OnabotulinumtoxinA
EXPERIMENTALParticipants will receive a single treatment of Placebo and OnabotulinumtoxinA.
Interventions
Intramuscular injection
Intramuscular injection
Eligibility Criteria
You may qualify if:
- Has moderate or severe glabellar lines (GL) at maximum frown as assessed by both the investigator and participant using the Facial Wrinkle Scale (FWS).
- Must be in good health as per investigator's judgment based on medical history, physical examination, vital sign measurements, 12-lead ECG parameters, clinical laboratory evaluations, and neurological assessment.
You may not qualify if:
- Active infection or dermatological condition at the treatment injection sites.
- History of immunization to any botulinum neurotoxin serotype or hypersensitivity to any botulinum neurotoxin serotype or any other constituents of the study drug or its excipients, and/or other products in the same class.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (8)
Investigate MD /ID# 270771
Scottsdale, Arizona, 85260, United States
Eye Research Foundation /ID# 270827
Newport Beach, California, 92663, United States
Marcus Facial Plastic Surgery /ID# 270770
Redondo Beach, California, 90277, United States
Skin Research Institute LLC /ID# 270831
Coral Gables, Florida, 33146-1837, United States
Skincare Physicians /ID# 271018
Chestnut Hill, Massachusetts, 02467, United States
Wilmington Dermatology Center /ID# 270828
Wilmington, North Carolina, 28403, United States
Austin Institute for Clinical Research - Pflugerville /ID# 270834
Pflugerville, Texas, 78660, United States
SkinDC /ID# 270932
Arlington, Virginia, 22209, United States
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 14, 2025
First Posted
February 19, 2025
Study Start
February 18, 2025
Primary Completion
November 3, 2025
Study Completion
November 3, 2025
Last Updated
November 17, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share