Press Release
| Phase 1 Sigle Ascending Dose Clinical Trail in 42 Health Volunteers |
| Date:2022-07-01 17:17:14 | Visits： |
The IND application (IND# 146206) supporting the evaluation of PSP001 injection was submitted by Prosit Sole Biotechnology (Beijing) Co., Ltd. On February 5, 2021, the company received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) for a Phase 1 clinical trial to evaluate the safety of PSP001 in healthy subjects. A total number of 42 subjects were randomized into the Phase 1a single ascending dose (SAD) study. The data exhibit good safety profile of PSP001. No serious treatment-emergent adverse events in the 42 subjects were noted. In the SAD study, a Grade 3 Liver transaminase elevation occurred with 1 subject out of 2 from cohort 6 sentinel pair. Elevated AST and ALT on D4, on D10, AST was recovered to normal range and ALT was partial restored. The study was stopped by the decision of SRC (Satety Review Committee), as agreed in clinical study protocol PSP001-101, the trial would be stopped once a Grade 3 Liver transaminase elevation occurred. The maximum tolerated dose of PSP001 in SAD study had been established. |
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