Study to Assess PK, Safety and Tolerability in Healthy Subjects
NCT06380699 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2024-07-24
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.
Conditions
- Acute Ischemic Stroke
Interventions
- DRUG
-
QHRD106 Injection
PEG-tissue kallikrein-1
- DRUG
-
Human Urinary Kallidinogenase
tissue kallikrein-1
- DRUG
-
placebo
Sponsors & Collaborators
-
Changzhou Qianhong Bio-pharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Juan Li, Doctor · The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2023-03-16
- Primary Completion
- 2023-11-16
- Completion
- 2023-12-25
Countries
- China
Study Locations
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