A Phase 1 Study to Evaluate the Safety and Tolerability of CBL-514 Injection on Convexity or Fullness of Abdominal Subcutaneous Fat in Healthy Volunteers

Sponsor
Caliway Biopharmaceuticals Co., Ltd.
Study ID
NCT04699669
Phase
PHASE1
Status
Completed

Conditions

  • Subcutaneous Fat

Eligibility Criteria

Sex
ALL
Age
18 Years - 64 Years
Healthy Volunteers
Accepted

Interventions

  • CBL-514, placebo — DRUG
    One side of the abdominal region will receive CBL-514, while the other will receive placebo with equal volume. Which side of the abdominal region to receive CBL-514 or placebo would be randomized. No PK samples will be collected in this cohort.
  • CBL-514, placebo — DRUG
    One side of the abdominal region will receive CBL-514, while the other will receive placebo with equal volume. Which side of the abdominal region to receive CBL-514 or placebo would be randomized.
  • CBL-514 — DRUG
    Both sides of the abdominal region will receive CBL-514.

Study Details

The Phase 1 component of the study is a double-blind, placebo-controlled, single ascending dose (SAD) design intended to assess the safety, tolerability, and PK of CBL-514. The SAD part will involve 9 proposed dosing cohorts.

Key Dates

Start date
Nov 27, 2018
Status verified
Jan 2021
Primary completion
Aug 20, 2019
Completion
Aug 20, 2019

Study Design

Enrollment
40 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Other: Cohort 1: CBL-514 2 mg, 0.5 mg/cm^2
    Individual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm\^2
  • Other: Cohort 2: CBL-514 10 mg, 0.5 mg/cm^2
    Individual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm\^2
  • Other: Cohort 3: CBL-514 20 mg, 0.5 mg/cm^2
    Individual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm\^2
  • Other: Cohort 4: CBL-514 40 mg, 1.0 mg/cm^2
    Individual placebo control. CBL-514 will be administrated with the grid spacing of 4 cm\^2
  • Other: Cohort 5: CBL-514 40 mg, 2 mg/cm^2
    Individual placebo control. CBL-514 will be administrated with the grid spacing of 2 cm\^2
  • Experimental: Cohort 6: CBL-514 80 mg, 2 mg/cm^2
    CBL-514 only. CBL-514 will be administrated with the grid spacing of 2 cm\^2
  • Experimental: Cohort 7: CBL-514 160 mg, 2 mg/cm^2
    CBL-514 only. CBL-514 will be administrated with the grid spacing of 2 cm\^2
  • Experimental: Cohort 8: CBL-514 240 mg, 2 mg/cm^2
    CBL-514 only. CBL-514 will be administrated with the grid spacing of 2 cm\^2
  • Experimental: Cohort 9: CBL-514 320 mg, 2 mg/cm^2
    CBL-514 only. CBL-514 will be administrated with the grid spacing of 2 cm\^2

Primary Outcome Measure

Incidence of treatment emergent adverse events (TEAEs) [ Time Frame: Up to 4 weeks after treatment ]

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