NCT04699669

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

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)

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Caliway Biopharmaceuticals Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Subcutaneous Fat

Interventions

Type	Name	Description
DRUG	CBL-514, placebo	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.
DRUG	CBL-514, placebo	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.
DRUG	CBL-514	Both sides of the abdominal region will receive CBL-514.

Timeline

• Start date: 2018-11-27
• Primary completion: 2019-08-20
• Completion: 2019-08-20
• First posted: 2021-01-07
• Last updated: 2021-01-07

Locations

1 site across 1 country: Australia