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COMPLETED
NCT06151561
PHASE1

Study of AGN-151586 in Japanese Participants With Moderate to Severe Glabellar Lines

Sponsor: AbbVie

View on ClinicalTrials.gov

Summary

Facial lines that develop from repeated facial expression, such as glabellar lines (GL), are typically treated by selectively weakening specific muscles with small quantities of botulinum toxin. The purpose of this study is to evaluate the safety and efficacy of AGN-151586 over a range of doses for the treatment of moderate to severe GL in Japanese participants. AGN-151586 is an investigational product being developed for the treatment of GL. Participants are randomly assigned to receive AGN-151586 or placebo. There is 1 in a 4 chance that participants will receive placebo. Around 24 adult participants with moderate to severe GL will be enrolled in the study in approximately 2 sites in Japan. Participants will receive either AGN-151586 or Placebo administered as 5 intramuscular injections to the glabellar complex on Day 1. The duration of the study will be approximately 6 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Official title: A Phase 1/2, Randomized, Double-Blinded, Placebo-Controlled Study of AGN-151586 in the Treatment of Japanese Subjects With Moderate to Severe Glabellar Lines

Key Details

Gender

All

Age Range

18 Years - 64 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2024-01-05

Completion Date

2024-04-03

Last Updated

2026-06-26

Healthy Volunteers

No

Interventions

DRUG

AGN-151586

Intramuscular Injection

DRUG

Placebo

Intramuscular Injection

Locations (1)

Tokyo Center Clinic /ID# 257898

Central District, Tokyo, Japan