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ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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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)
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
Timeline
Interventions
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.
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.
Both sides of the abdominal region will receive CBL-514.