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Clinical Trial Summary

This Phase 2 study will be an open-label and single course study to assess the safety, tolerability, PK and metabolite profile of CBL-514.


Clinical Trial Description

This is a Phase 2 study to evaluate the safety, tolerability, PK and metabolite profile of CBL-514 injection at the maximal use dosage. This Phase 2 study has an open-label and single course design. A total of 10 adult participants, composed of 5 females and 5 males, will be enrolled in a single cohort. Each participant will receive a single course of treatment with CBL-514 800 mg on the abdomen (administered as multiple subcutaneous injections) on Day 1 only. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05234736
Study type Interventional
Source Caliway Biopharmaceuticals Co., Ltd.
Contact
Status Completed
Phase Phase 2
Start date February 11, 2022
Completion date June 9, 2022

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