Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06380699
Status:
COMPLETED
Last Update Posted:
2024-04-26
First Post:
2024-04-16
Brief Title:
Study to Assess PK Safety and Tolerability in Healthy Subjects
Sponsor:
Changzhou Qianhong Bio-pharma Co Ltd
Organization:
Changzhou Qianhong Bio-pharma Co Ltd
Study Overview
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
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 daysn 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None