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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

Subcutaneous Fat Clinical Trial

Official title:
A 2-stage, Phase 1/2a Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of CBL-514 Injection for Reducing Convexity or Fullness of Abdominal Subcutaneous Fat (Phase 1)

Clinical Trial Summary

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.

Clinical Trial Description

The Phase 1 part of the study was a first-in-human, single ascending dose, double-blind, randomized (except Cohorts 6 to 9 [open-label]) study in healthy subjects to evaluate the safety, tolerability and PK of CBL-514, and to determine the dose levels to be used for the Phase 2a part of the study. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04699669
Study type Interventional
Source Caliway Biopharmaceuticals Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date November 27, 2018
Completion date August 20, 2019
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