NCT04111523

Single-dose Incremental Intravenous Injection of SY-007 in Healthy Subjects

Phase I Clinical Study to Evaluate Safety, Tolerance and Pharmacokinetics of SY-007 After Single-dose Incremental Intravenous Injection in Healthy Subjects

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Suzhou Yabao Pharmaceutical R&D Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Six dose-group trials are planned: 1 mg,4 mg,10 mg,20 mg,30 mg,and 45 mg.When the dose reaches 45mg, if the standard of increasing dose termination is still not reached, the researcher and the sponsor shall decide whether to continue the increasing dose after reviewing the previous study data, and each increasing dose shall not exceed 33.3% (e.g., 60mg) of the previous dose group. In the process of dose increasing, when the dose exceeds 20 mg, if the dose level reaches the dose termination standard, an intermediate dose is set between this dose and the previous dose, and the study is returned to the intermediate dose group.In this study, a parallel design was adopted, in which each subject received only one dose of drug from one dose group, which ensured the safety of the subject to the greatest extent, and also avoided the interference of safety and PK results caused by possible insufficient elution or other factors.Among them, 1 mg dose group was the starting dose group, and 6 subjects were randomly assigned into sy-007 group for injection or placebo group at a ratio of 2:1. Only 2 subjects were given the drug for the first time. One day after the first two subjects were given the drug, after ensuring the safety of the first two subjects, the drug was given to the remaining 4 subjects.In other dose groups, sentry administration was also used. The first 2 subjects received sy-007 injection or placebo respectively. After 3 days of hospitalization observation, the safety data of the first 2 cases were reviewed by the researcher and the sponsor, and the remaining subjects in this dose group were determined accordingly.Pharmacokinetic biological samples were collected from all dose groups and their safety was assessed.A total of 66\~90 healthy subjects will be enrolled.

Conditions

• Cerebral Apoplexy

Interventions

Type	Name	Description
DRUG	SY-007	A single dose of SY-007 or placebo injection(1mg-45mg)

Timeline

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

Locations

1 site across 1 country: China