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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)

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06834789
Enrollment
132
Registered
2025-02-19
Start date
2025-02-18
Completion date
2025-11-03
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glabellar Lines

Keywords

Glabellar Lines, AGN-151586, OnabotulinumtoxinA

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).

Interventions

DRUGAGN-151586

Intramuscular injection

DRUGOnabotulinumtoxinA

Intramuscular injection

DRUGPlacebo

Intramuscular injection

Sponsors

AbbVie
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants with Adverse Events (AEs)Up to approximately 10.4 monthsAn 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.
Number of Participants with the Presence of Binding and Neutralizing Antidrug Antibodies to AGN-151586 and/or OnabotulinumtoxinAUp to approximately 10.4 monthsSamples collected from participants treated with AGN-151586 and OnabotulinumtoxinA will be analyzed for antibodies against both AGN-151586 and OnabotulinumtoxinA.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026