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A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 1)

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 1)

Clinical Trial Summary

The Stage 1 of this phase 2 study is an open-label single ascending dose (SAD) 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 1 will include a total of 12 participants enrolled in 3 sequential escalating CBL-514 dose groups.The groups will be open label and each group will enroll 4 participants. Eligible participants will be sequentially assigned to receive 1 course 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 NCT05632926
Study type Interventional
Source Caliway Biopharmaceuticals Co., Ltd.
Contact
Status Completed
Phase Phase 2
Start date January 9, 2023
Completion date May 3, 2023
View Details
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