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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1: AGN-151586 Dose A and OnabotulinumtoxinA | Experimental | Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA. |
|
| Cohort 2: AGN-151586 Dose B and OnabotulinumtoxinA | Experimental | Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA. |
|
| Cohort 3: AGN-151586 Dose A and OnabotulinumtoxinA | Experimental | Participants will receive a single treatment of AGN-151586 Dose A and OnabotulinumtoxinA. |
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| Cohort 3: AGN-151586 Dose B and OnabotulinumtoxinA | Experimental | Participants will receive a single treatment of AGN-151586 Dose B and OnabotulinumtoxinA. |
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| Cohort 3: Placebo and OnabotulinumtoxinA | Experimental | Participants will receive a single treatment of Placebo and OnabotulinumtoxinA. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AGN-151586 | Drug | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigate MD /ID# 270771 | Scottsdale | Arizona | 85260 | United States | ||
| Eye Research Foundation /ID# 270827 |
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| OnabotulinumtoxinA | Drug | Intramuscular injection |
|
| Placebo | Drug | Intramuscular injection |
|
| 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 |
| ID | Term |
|---|---|
| D019274 | Botulinum Toxins, Type A |
| ID | Term |
|---|---|
| D001905 | Botulinum Toxins |
| D008666 | Metalloendopeptidases |
| D010450 | Endopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045726 | Metalloproteases |
| D001426 | Bacterial Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001427 | Bacterial Toxins |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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