Study to Assess PK, Safety and Tolerability in Healthy Subjects

Acute Ischemic Stroke Clinical Trial

Official title: Phase I Clinical Study of Tolerability, Safety and Pharmacokinetics of QHRD106 Injection in Chinese Healthy Subjects With Single and Multiple Doses

Status Completed

Clinical Trial Summary

The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of QHRD106 in Chinese healthy subjects with single and multiple doses.

Clinical Trial Description

Three dose groups were initially set up. The experimental groups were increased from low to high dose according to the principle of increasing dose, and Urinary kallidinogenase for injection was added as the positive control group. All the selected subjects in the experimental group were given the drug once. Combined with the existing human PK and safety test data, the expected human exposure of the dose group to be increased was still in the range of the lowest safe exposure proved by preclinical toxicology studies, and the safety of the dose to be increased was controllable in humans. The positive control group could be carried out at any time during the single dose increasing stage, and the positive control drug was given once a day for 7 consecutive days.n the stage of multiple dose escalation, QHRD106 injection is intended to be administered in 5600IU, 8400IU and 12600IU dosage groups. When the single dose tolerance observation of each dose is completed and the dose escalation termination standard is not reached, the corresponding dose multiple dose escalation study can be selected. Ten subjects in each group were given medicine once a week for 4 consecutive times. ;

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemic Stroke

• NCT number: NCT06380699
• Study type: Interventional
• Source: Changzhou Qianhong Bio-pharma Co., Ltd.
• Status: Completed
• Phase: Phase 1
• Start date: March 16, 2023
• Completion date: December 25, 2023