NCT05632926

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

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Caliway Biopharmaceuticals Co., Ltd. · Industry
• Sex: Female
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

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 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.

Conditions

• Cellulite

Interventions

Type	Name	Description
DRUG	40 mg CBL-514	CBL-514 will be administered at the raised area of cellulite.
DRUG	60 mg CBL-514	CBL-514 will be administered at the raised area of cellulite.
DRUG	80 mg CBL-514	CBL-514 will be administered at the raised area of cellulite.

Timeline

• Start date: 2023-01-09
• Primary completion: 2023-05-03
• Completion: 2023-05-03
• First posted: 2022-12-01
• Last updated: 2023-06-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study