Trials / Completed
CompletedNCT05836779
A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 2)
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)
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 23 (actual)
- Sponsor
- Caliway Biopharmaceuticals Co., Ltd. · Industry
- Sex
- Female
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | CBL-514 injection | CBL-514 will be administered at the raised area of cellulite. |
Timeline
- Start date
- 2023-05-10
- Primary completion
- 2023-11-29
- Completion
- 2024-01-05
- First posted
- 2023-05-01
- Last updated
- 2024-05-16
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05836779. Inclusion in this directory is not an endorsement.