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Clinical Trial Summary

To evaluate the safety and tolerability of Hepalatide(L47) and characterize the clinical pharmacokinetics in healthy volunteers.


Clinical Trial Description

This is a randomized, double-blinded, dose escalating, phase Ia trial, which will be conducted in No. 302 Hospital of China. There are seven cohorts at dose of 0.21mg, 0.525mg, 2.1mg, 4.2mg, 6.3mg, 8.4mg and 10.5mg. The first cohort with 0.21mg is an open test with no placebo as control. All other healthy volunteers will be randomized into Hepalatide or placebo group at 4:1 rate, and will be received drug by abdominal subcutaneous injection and will be observed for 8 days. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02612506
Study type Interventional
Source Shanghai HEP Pharmaceatical Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date October 2015
Completion date August 2016

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