CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 40 enrolled
Drug / intervention
CBL-514, placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

In the news

4 articles

Matched to this trial by ClinicalIndexfrom reputable biotech & medical press.

Search/NCT04699669
NCT04699669Phase 1Completed

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)

Caliway Biopharmaceuticals Co., Ltd.·interventional·Posted Jan 7, 2021·Updated Jan 7, 2021

In Brief

A Phase 1 clinical trial evaluating CBL-514, placebo and CBL-514 for Subcutaneous Fat. Completed, enrolled 40 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia
Collaborators--

Timeline

Phase 1CompletedFinished
20192020202120222023202420252026
First PostedJan 7, 2021
Enrollment StartNov 27, 2018
Primary CompletionAug 20, 2019
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 5.5 years ago

Interventions

CBL-514, placebodrug

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, placebodrug

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-514drug

Both sides of the abdominal region will receive CBL-514.