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Clinical Trials/NCT05110118
NCT05110118CompletedPhase 1

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

Shandong Boan Biotechnology Co., Ltd1 site in 1 country112 target enrollmentStarted: August 4, 2020Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Completed
Enrollment
112
Locations
1
Primary Endpoint
Terminal elimination half-life(t1/2)

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
18 Years to 45 Years (Adult)
Sex
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

Arms & Interventions

LY01008

Experimental

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

Intervention: LY01008 (Drug)

Avastin

Active Comparator

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

Intervention: Avastin (Drug)

Outcomes

Primary Outcomes

Terminal elimination half-life(t1/2)

Time Frame: From baseline to Day 99

Apparent volume of distribution(Vd)

Time Frame: From baseline to Day 99

Maximum (peak) plasma concentration(Cmax)

Time Frame: 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

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

Time Frame: From baseline to Day 99

Chloride(CL)

Time Frame: From baseline to Day 99

Secondary Outcomes

  • Vital signs(From baseline to Day 99)
  • Clinical laboratory tests(From baseline to Day 99)
  • Positive rate of neutralizing antibody (NAb)(From baseline to Day 99)
  • Adverse Events(AEs)(From baseline to Day 99)
  • Physical examinations(From baseline to Day 99)
  • 12-lead ECGs(From baseline to Day 99)
  • Positive rate of serum anti-drug antibody (ADA)(From baseline to Day 99)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (1)

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