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Clinical Trial Summary

This study includes a dose escalation part(phase I) and a dose extension part(phase II).


Clinical Trial Description

In phase I of this study, a multi-center, randomized, placebo parallel control design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.A total of 40 subjects are expected to be enrolled in about 4 centers. In phase II of this study, a multi-center, randomized, double-blind parallel, placebo-controlled design was adopted. Enrolled subjects were randomly assigned to the experimental group or the placebo group.About 120 subjects are expected to be enrolled in about 10 centers. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04445363
Study type Interventional
Source Suzhou Zelgen Biopharmaceuticals Co.,Ltd
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Status Active, not recruiting
Phase Phase 1/Phase 2
Start date August 12, 2020
Completion date December 1, 2024