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A Phase I Study Evaluating the Single Subcutaneous Injection of Ebronucimab With Different Production Processes in Chinese Healthy Male Subjects
This is a phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects.
This is a randomized, parallel controlled, phase I clinical study to evaluate the pharmacokinetics (PK) similarity of single dose subcutaneous injection of Ebronucimab with different production processes in Chinese healthy male subjects. This study consists of two parts: pre-trial part and formal-trial part, with a planned enrollment of approximately 180 healthy male participants from China.
Age
18 - 45 years
Sex
MALE
Healthy Volunteers
Yes
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Start Date
November 4, 2024
Primary Completion Date
April 30, 2025
Completion Date
June 17, 2025
Last Updated
October 15, 2024
180
ESTIMATED participants
Ebronucimab
DRUG
Ebronucimab
DRUG
Lead Sponsor
Akeso
NCT07114146
NCT06884488
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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View ClinicalTrials.gov Terms and ConditionsNCT06846658