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