A Study to Evaluate the Efficacy, Safety and Tolerability of CBL-514 Injection for Reducing Subcutaneous Fat (Stage 1)

Sponsor
Caliway Biopharmaceuticals Co., Ltd.
Study ID
NCT04575467
Phase
PHASE2
Status
Completed

Conditions

  • Subcutaneous Fat

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • CBL-514 — DRUG
    CBL-514 will be administered via injection into the subcutaneous adipose layer.

Study Details

The Stage 1 of this phase 2 study is an open-label single ascending dose (SAD) study. The primary objectives are to evaluate the safety and tolerability of injection lipolysis with CBL-514. It will be followed by a parallel-arm multiple-dose design in Stage 2.

Key Dates

Start date
Dec 9, 2020
Status verified
Jul 2024
Primary completion
Nov 15, 2021
Completion
Dec 8, 2021

Study Design

Enrollment
25 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: CBL-514 320 mg
    CBL-514 will be administered via injection into the thigh subcutaneous adipose layer.
  • Experimental: CBL-514 480 mg
    CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
  • Experimental: CBL-514 640 mg
    CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.
  • Experimental: CBL-514 800 mg
    CBL-514 will be administered via injection into the abdomen subcutaneous adipose layer.

Primary Outcome Measure

Number of Treatment Emergent Adverse Events [ Time Frame: Up to 4 weeks after treatment ]

Related Studies