Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-25 @ 8:50 PM
Study NCT ID:
NCT04699669
Status:
COMPLETED
Last Update Posted:
2021-01-07
First Post:
2020-12-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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.
Organization:
Study Overview
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)
Status:
COMPLETED
Status Verified Date:
2021-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: