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)

AbbVie

Status and phase: Enrolling; Phase 1

Conditions: Glabellar Lines

Treatments: Drug: Placebo; Drug: OnabotulinumtoxinA; Drug: AGN-151586

Study type: Interventional

Funder types: Industry

Identifiers

NCT06834789

M25-207

Details and patient eligibility

About

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).

Enrollment: 126 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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126 participants in 5 patient groups

Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA

Experimental group

Description:

Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.

Treatment:

Drug: AGN-151586

Drug: OnabotulinumtoxinA

Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA

Experimental group

Description:

Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.

Treatment:

Drug: AGN-151586

Drug: OnabotulinumtoxinA

Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA

Experimental group

Description:

Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA.

Treatment:

Drug: AGN-151586

Drug: OnabotulinumtoxinA

Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA

Experimental group

Description:

Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA.

Treatment:

Drug: AGN-151586

Drug: OnabotulinumtoxinA

Cohort 3: Placebo and OnabotulinumtoxinA

Experimental group

Description:

Participants will receive a single treatment of Placebo and OnabotulinumtoxinA.

Treatment:

Drug: OnabotulinumtoxinA

Drug: Placebo