A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal Subcutaneous Fat

Sponsor
Caliway Biopharmaceuticals Co., Ltd.
Study ID
NCT04698642
Phase
PHASE2
Status
Completed

Conditions

  • Subcutaneous Fat

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • CBL-514 — DRUG
    Both sides of the abdominal region will receive CBL-514.

Study Details

The Phase 2a component of the study will be a randomized, open-label, parallel, and multiple dose study to further examine the safety and efficacy profile of 3 CBL-514 dose levels based on the results from Phase 1 of the study.

Key Dates

Start date
Feb 3, 2020
Status verified
Jan 2021
Primary completion
Nov 12, 2020
Completion
Nov 12, 2020

Study Design

Enrollment
43 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CBL-514 180 mg, 1.2 mg/cm^2
    CBL-514 will be administrated with the grid spacing of 2.5 cm\^2
  • Experimental: CBL-514 240 mg, 1.6 mg/cm^2
    CBL-514 will be administrated with the grid spacing of 2.5 cm\^2
  • Experimental: CBL-514 300 mg, 2 mg/cm^2
    CBL-514 will be administrated with the grid spacing of 2.5 cm\^2

Primary Outcome Measure

Change of abdominal subcutaneous fat volume [ Time Frame: Up to 8 weeks after last treatment ]

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