A Study to Evaluate the Efficacy and Safety of CBL-514 in Participants With EFP; Cellulite (Stage 1)
Part of paid clinical trials in Encino, California.
- Sponsor
- Caliway Biopharmaceuticals Co., Ltd.
- Study ID
- NCT05632926
- Phase
- PHASE2
- Status
- Completed
Conditions
- Cellulite
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 64 Years
- Healthy Volunteers
- Not accepted
Interventions
- 40 mg CBL-514 — DRUGCBL-514 will be administered at the raised area of cellulite.
- 60 mg CBL-514 — DRUGCBL-514 will be administered at the raised area of cellulite.
- 80 mg CBL-514 — DRUGCBL-514 will be administered at the raised area of cellulite.
Study Details
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.
Key Dates
- Start date
- Jan 9, 2023
- Status verified
- Jun 2023
- Primary completion
- May 3, 2023
- Completion
- May 3, 2023
Study Design
- Enrollment
- 12 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SEQUENTIAL
- Primary purpose
- TREATMENT
Arms
- Experimental: CBL-514 40mg
- Experimental: CBL-514 60mg
- Experimental: CBL-514 80mg
Primary Outcome Measure
Evaluation of the improvement of edematous fibrosclerotic panniculopathy (EFP) measured by cellulite severity scale from baseline following administration of 1 course of CBL-514. [ Time Frame: Up to 4 weeks from treatment visit ]
Locations (2)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Investigational Site 1 | Encino | California | 91436 | - |
| Investigational Site 2 | New York | New York | 10022 | - |
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