- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05110118
Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects
October 27, 2021 updated by: Shandong Boan Biotechnology Co., Ltd
A Randomized, Double-blind, Single-dose, Parallel-group Study Comparing Pharmacokinetic Characteristics, Safety , Tolerability and Immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in Healthy Chinese Male Subjects
This is a randomized, double-blind, single-dose, parallel-group study comparing pharmacokinetic characteristics, safety , tolerability and immunogenicity of LY01008 (Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection) and Avastin (Bevacizumab Injection) in healthy Chinese male subjects.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
112
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Anhui
-
Hefei, Anhui, China
- The Second Hospital of Anhui Medical University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 43 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy male volunteers
- Subjects aged 18 - 45 years
- Subjects weighing ≥ 50.0 kg and ≤ 100.0 kg
- Subjects with a body mass index (BMI) ≥ 19.0 and ≤ 26.0 kg/m2
Exclusion Criteria:
- Subjects with evidence or history of clinically significant disease
- Subjects with a history of previous cancer
- Subjects with a history of hypertension, or abnormal blood pressure at screening/baseline measurements (systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg confirmed by a repeat measurement on the same day)
- Subjects with a history of blood donation 3 months before study drug infusion
- Subjects with a history of exposure to antibodies 12 months before study drug infusion
- Subjects with previous exposure to anti-VEGF therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: LY01008
Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min).
|
Single intravenous injection
Other Names:
|
Active Comparator: Avastin
Single intravenous injection of Avastin 3 mg/kg for 90 min(±1 min).
|
Single intravenous injection
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Area under the plasma concentration-time curve from time zero to the last measurable concentration(AUC0-t)
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
Maximum (peak) plasma concentration(Cmax)
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
Chloride(CL)
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
Terminal elimination half-life(t1/2)
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
Apparent volume of distribution(Vd)
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Adverse Events(AEs)
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
Vital signs
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
Physical examinations
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
Clinical laboratory tests
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
12-lead ECGs
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
Positive rate of serum anti-drug antibody (ADA)
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
Positive rate of neutralizing antibody (NAb)
Time Frame: From baseline to Day 99
|
From baseline to Day 99
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 4, 2020
Primary Completion (Actual)
January 13, 2021
Study Completion (Actual)
January 13, 2021
Study Registration Dates
First Submitted
October 25, 2021
First Submitted That Met QC Criteria
October 27, 2021
First Posted (Actual)
November 5, 2021
Study Record Updates
Last Update Posted (Actual)
November 5, 2021
Last Update Submitted That Met QC Criteria
October 27, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Carcinoma, Bronchogenic
- Bronchial Neoplasms
- Lung Neoplasms
- Carcinoma, Non-Small-Cell Lung
- Physiological Effects of Drugs
- Antineoplastic Agents
- Antineoplastic Agents, Immunological
- Angiogenesis Inhibitors
- Angiogenesis Modulating Agents
- Growth Substances
- Growth Inhibitors
- Bevacizumab
- Endothelial Growth Factors
Other Study ID Numbers
- LY01008/CT-CHN-103
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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