Caliway Biopharmaceuticals (TPE:6919) submitted an investigational new drug (IND) application to China's National Medical Products Administration's Center for Drug Evaluation for a phase one study of abdominal fact reduction drug.
The CBL-0102 trial will evaluate the safety, tolerability and pharmacokinetic profile of CBL-514 in about 30 healthy Chinese subjects, following completion of a pre-IND meeting with the regulator.
The company said the localized phase 1 study will assess potential racial differences in the drug's efficacy and safety between Chinese and non-Chinese populations, with a China phase 3 application planned after the phase 1 study is completed.