NCT06388772

Study to Assess PK, Safety and Tolerability Early in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Changzhou Qianhong Bio-pharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

Eight dose groups were initially set up. The experimental groups were increased from low to high dose according to the principle of increasing dose, and Placebo was added as the control group. All the selected subjects in the experimental group were given the drug once.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	QHRD106 Injection	250IU\~8400IU,pegylated(PEG)-tissue kallikrein-1
DRUG	placebo	placebo

Timeline

• Start date: 2021-07-05
• Primary completion: 2022-07-22
• Completion: 2023-01-06
• First posted: 2024-04-29
• Last updated: 2024-07-24

Locations

1 site across 1 country: China