CBL-514 80mg for Cellulite

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Cellulite+1 More40 mg CBL-514 - Drug
Eligibility
18 - 64
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Cellulite

Treatment Effectiveness

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 4 weeks from treatment visit

Week 4
Evaluation of the improvement of edematous fibrosclerotic panniculopathy (EFP) measured by cellulite severity scale from baseline following administration of 1 course of CBL-514.
Incidence of adverse events and treatment-emergent adverse events (TEAEs)
Incidence of adverse events and treatment-emergent adverse events (TEAEs) at the injection site(s)
Incidence of adverse events and treatment-emergent adverse events (TEAEs) related to the investigational product (IP)
Incidence of adverse events of special interest
Incidence of use of concomitant medications to treat treatment-emergent adverse events (TEAEs)
Number of participants with clinically significant abnormalities in laboratory tests
Number of participants with clinically significant abnormalities in physical examination

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

3 Treatment Groups

CBL-514 80mg
1 of 3
CBL-514 60mg
1 of 3
CBL-514 40mg
1 of 3

Experimental Treatment

12 Total Participants · 3 Treatment Groups

Primary Treatment: CBL-514 80mg · No Placebo Group · Phase 2

CBL-514 80mg
Drug
Experimental Group · 1 Intervention: 80 mg CBL-514 · Intervention Types: Drug
CBL-514 60mg
Drug
Experimental Group · 1 Intervention: 60 mg CBL-514 · Intervention Types: Drug
CBL-514 40mg
Drug
Experimental Group · 1 Intervention: 40 mg CBL-514 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 4 weeks from treatment visit

Who is running the clinical trial?

Caliway Biopharmaceuticals Co., Ltd.Lead Sponsor
6 Previous Clinical Trials
204 Total Patients Enrolled
Anne SheuStudy DirectorCaliway Biopharmaceuticals Co., Ltd.
3 Previous Clinical Trials
97 Total Patients Enrolled

Eligibility Criteria

Age 18 - 64 · Female Participants · 7 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are female aged 18 years to 64 years old.
The number of evident depressions is ≥ 1.
The depth of depressions score is ≥ 1.
You have both sides of posterolateral thighs assessed according to the modified Hexsel CSS