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A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2)

Cellulite Clinical Trial

Official title:
A Phase 2a, Open Label Study to Evaluate the Safety, Tolerability, and Efficacy of CBL-514 Injection for the Treatment of Edematous Fibrosclerotic Panniculopathy (EFP) Cellulite (Stage 2)

Clinical Trial Summary

The Stage 2 of this phase 2 study is an open-label, single-arm study to assess the efficacy and safety of CBL-514 in participants with Edematous Fibrosclerotic Panniculopathy (EFP) cellulite.

Clinical Trial Description

This Phase 2a study has an integrated design consisting of a single ascending dose (SAD) part in Stage 1 followed by a single-arm design in Stage 2. The Stage 2 will include a total of 20 participants enrolled in 1 selected CBL-514 dose. Eligible participants will be sequentially assigned to receive up to 2 courses of allocated CBL-514 dose administered by subcutaneous injection on both sides of the posterolateral thighs. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05836779
Study type Interventional
Source Caliway Biopharmaceuticals Co., Ltd.
Contact
Status Active, not recruiting
Phase Phase 2
Start date May 10, 2023
Completion date January 2024
View Details
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