NCT06380699

Study to Assess PK, Safety and Tolerability in Healthy Subjects

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 56 (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, pharmacokinetics (PK) and pharmacodynamics (PD) of QHRD106 in Chinese healthy subjects with single and multiple doses.

Detailed 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, 8400 IU and 12600 IU 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.

Conditions

• Acute Ischemic Stroke

Interventions

Type	Name	Description
DRUG	QHRD106 Injection	PEG-tissue kallikrein-1
DRUG	Human Urinary Kallidinogenase	tissue kallikrein-1
DRUG	placebo	placebo

Timeline

• Start date: 2023-03-16
• Primary completion: 2023-11-16
• Completion: 2023-12-25
• First posted: 2024-04-24
• Last updated: 2024-07-24

Locations

1 site across 1 country: China