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Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin in Healthy Chinese Male Subjects

Sponsor
Shandong Boan Biotechnology Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT05110118
Collaborator
(none)
112
Enrollment
1
Location
2
Arms
5.3
Actual Duration (Months)
21
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
112 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date :
Aug 4, 2020
Actual Primary Completion Date :
Jan 13, 2021
Actual Study Completion Date :
Jan 13, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: LY01008

Single intravenous injection of LY01008 3 mg/kg for 90 min(±1 min).

Drug: LY01008
Single intravenous injection
Other Names:
  • Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection

    		•
    Active Comparator: Avastin

    Single intravenous injection of Avastin 3 mg/kg for 90 min(±1 min).

    Drug: Avastin
    Single intravenous injection
    Other Names:
  • Bevacizumab

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Area under the plasma concentration-time curve from time zero to the last measurable concentration（AUC0-t） [From baseline to Day 99]

    2. Area under the plasma concentration-time curve from time zero to infinity（AUC0-∞） [From baseline to Day 99]

    3. Maximum (peak) plasma concentration（Cmax） [From baseline to Day 99]

    4. Chloride（CL） [From baseline to Day 99]

    5. Terminal elimination half-life（t1/2） [From baseline to Day 99]

    6. Apparent volume of distribution（Vd） [From baseline to Day 99]

    Secondary Outcome Measures

    1. Adverse Events(AEs) [From baseline to Day 99]

    2. Vital signs [From baseline to Day 99]

    3. Physical examinations [From baseline to Day 99]

    4. Clinical laboratory tests [From baseline to Day 99]

    5. 12-lead ECGs [From baseline to Day 99]

    6. Positive rate of serum anti-drug antibody (ADA) [From baseline to Day 99]

    7. Positive rate of neutralizing antibody (NAb) [From baseline to Day 99]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Hospital of Anhui Medical University Hefei Anhui China

    Sponsors and Collaborators

    • Shandong Boan Biotechnology Co., Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Shandong Boan Biotechnology Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT05110118
    Other Study ID Numbers:
    • LY01008/CT-CHN-103
    First Posted:
    Nov 5, 2021
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Lung Neoplasms
    Carcinoma, Non-Small-Cell Lung
    Bevacizumab
    Endothelial Growth Factors

    Study Results

    No Results Posted as of Nov 5, 2021