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Study to Assess PK, Safety and Tolerability in Healthy Subjects - Trial NCT06380699

Access comprehensive clinical trial information for NCT06380699 through Pure Global AI's free database. This Phase 1 trial is sponsored by Changzhou Qianhong Bio-pharma Co., Ltd. and is currently Completed. The study focuses on Acute Ischemic Stroke. Target enrollment is 56 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.

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NCT06380699
Phase 1
Completed
drug
Trial Details
ClinicalTrials.gov โ€ข NCT06380699
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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

Study Focus

Acute Ischemic Stroke

QHRD106 Injection

Interventional

drug

Sponsor & Location

Changzhou Qianhong Bio-pharma Co., Ltd.

Nanjing, China

Timeline & Enrollment

Phase 1

Mar 16, 2023

Dec 25, 2023

56 participants

Primary Outcome

Safety as assessed by incidence, severity, and causality of adverse events,Plasma measurements of QHRD106,Concentration of bradykinin in plasma

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.

ICD-10 Classifications

Stroke, not specified as haemorrhage or infarction
Sequelae of stroke, not specified as haemorrhage or infarction
Cerebral infarction
Cerebral infarction, unspecified
Transient cerebral ischaemic attack, unspecified

Data Source

ClinicalTrials.gov

NCT06380699

Non-Device Trial