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OpenTrials
Completed

NCT Number: NCT05110118

Pharmacokinetic Characteristics, Safety, Tolerability and Immunogenicity of LY01008 and Avastin 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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY01008

Drug

Single intravenous injection

Other names: Recombinant Humanized Anti-Human Vascular Endothelial Growth Factor Monoclonal Antibody Injection

Avastin

Drug

Single intravenous injection

Other names: Bevacizumab

Primary outcomes

  1. Area under the plasma concentration-time curve from time zero to the last measurable concentration(AUC0-t)

    Time frame: From baseline to Day 99

  2. Area under the plasma concentration-time curve from time zero to infinity(AUC0-∞)

    Time frame: From baseline to Day 99

  3. Maximum (peak) plasma concentration(Cmax)

    Time frame: From baseline to Day 99

  4. Chloride(CL)

    Time frame: From baseline to Day 99

  5. Terminal elimination half-life(t1/2)

    Time frame: From baseline to Day 99

  6. Apparent volume of distribution(Vd)

    Time frame: From baseline to Day 99

Secondary outcomes

  1. Adverse Events(AEs)

    Time frame: From baseline to Day 99

  2. Vital signs

    Time frame: From baseline to Day 99

  3. Physical examinations

    Time frame: From baseline to Day 99

  4. Clinical laboratory tests

    Time frame: From baseline to Day 99

  5. 12-lead ECGs

    Time frame: From baseline to Day 99

  6. Positive rate of serum anti-drug antibody (ADA)

    Time frame: From baseline to Day 99

  7. Positive rate of neutralizing antibody (NAb)

    Time frame: From baseline to Day 99

Sponsors and collaborators

Lead sponsor

Shandong Boan Biotechnology Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 5, 2021
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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