NCT04217629

Single-dose/Multiple-doses Incremental Intravenous Injection of SY-005 （Recombinant Human Annexin A5）in Healthy Subjects

Phase I Clinical Study to Evaluate Safety, Tolerance and Pharmacokinetics of SY-005 After Single-dose/Multiple-doses Incremental Intravenous Injection in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 96 (actual)
• Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This is a single-dose/multiple-doses incremental, randomized, double-blind, parallel, placebo-controlled study on safety, tolerance and pharmacokinetics healthy subjects.

Detailed description

This is a randomized, double-blind, placebo-controlled, dosed tolerability, pharmacokinetic study of a single-dose/multiple-doses incremental intravenous injection of SY-005（recombinant human annexin A5） in healthy subjects. Six sigle-dose group trials are planned: 0.75mg, 2.5mg, 5mg, 10mg, 15mg,and 20mg and three multiple-doses groups are planned: 5mg, 10mg and 20mg. Single-dose groups are planned to enroll 64 subjects and multiple-doses groups are planned to enroll 30 subjects.

Conditions

• Sepsis

Interventions

Type	Name	Description
DRUG	SY-005	This single-dose group will be initiated in healthy subjects at a 0.75mg dose that is the maximum recommended starting dose(MRSD). Doses will be escalated in subsequent dosing process, after appropriate review of safety data. The subsequent planned doses are2.5mg, 5mg, 10mg, 15mg, 20mg successively. The dose of multiple-doses groups are depending on the results of single-dose groups.

Timeline

• Start date: 2019-04-26
• Primary completion: 2019-10-05
• Completion: 2020-08-19
• First posted: 2020-01-03
• Last updated: 2021-06-03

Locations

1 site across 1 country: China