Spots Global Cancer Trial Database for A Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers
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Trial Identification
Brief Title: A Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers
Official Title: A Randomized, Double-blind, Single-dose, Parallel-group Study to Compare the Pharmacokinetics and Safety of QL1101 and EU-Avastin® in Healthy Volunteers
Study ID: NCT06232902
Conditions
Study Description
Brief Summary: The goal of this clinical trial is to compare the pharmacokinetic and safety similarity of QL1101 with EU-Avastin® in healthy male volunteers. Participants will receive a single injection of QL1101/ EU-Avastin®.Researchers will compare pharmacokinetic, safety, and immunogenic similarities between the 2 groups.
Detailed Description: This is a phase I,single center, randomized, double-blind and parallel group clinical trial . The primary objective is to assess the pharmacokinetic similarity of single injections of QL1101 or EU-Avastin® in healthy volunteers. The secondary objective are to assess the clinical safety and immunogenicity similarity of single injections of QL1101 or EU-Avastin® in healthy volunteers. Subjects would receive a single 100mg（4ml） of QL1101or EU-Avastin® injection.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT
Sex: MALE
Healthy Volunteers: Yes
Locations
The First Affiliated Hospital of Jilin University, Changchun, Jilin, China
Contact Details
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