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Completed

NCT Number: NCT04820439

Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection

This study was designed as a randomized, double-blind, parallelity-controlled study.Eighty-eight healthy male subjects (44 in each group) will be enrolled in this study.The aim of this clinical trial is to evaluate pharmacokinetic similarity between recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627) and Perjeta ® in a single intravenous infusion in healthy male subjects.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Phase I Clinical Research Center

Qingdao, Shandong, 266003, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy male aged 18-40.
  • The body mass index is in the range of 19-26 kg/m2 (including thecritical value). The weight is 50 kg-80kg.
  • The subjects have no family planning within 3 months and could select contraceptive method
  • The subjects who have signed the informed consent and are able to complete the experiment according to the trial protocol.
  • Echocardiography showed left ventricular ejection fraction (LVEF) > 50% ,which two weeks before administration of experimental drug.

Exclusion criteria

  • The subjects with a history of malignant tumor.
  • The subjects who has received any live vaccine within 6 months prior to signing the informed consent.
  • The subjects who has upper respiratory tract infection or other acute infections within the previous 2 weeks of screening.
  • The subjects who had undergone surgery within 2 months prior to signing the informed consent.
  • Anti-drug antibody (ADA) detection positive.
  • Previous treatment with any antibody targeting the HER2 receptor or Those who have used monoclonal antibodies within 6 months prior to signing the informed consent.

Treatment and study plan

recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)

Drug

A single intravenous infusion of HS627 420mg

Perjeta ®

Drug

A single intravenous infusion of Perjeta ®420mg

Primary outcomes

  1. Area under the plasma concentration versus time curve (AUC)0-∞

    Time frame: 150 days

    Evaluation of Area under the plasma concentration versus time curve (AUC)0-∞

  2. Area under the plasma concentration versus time curve (AUC)0-t

    Time frame: 150 days

    Evaluation of Area under the plasma concentration versus time curve (AUC)0-t

  3. Peak Plasma Concentration (Cmax)

    Time frame: 150 days

    Evaluation of Peak Plasma Concentration (Cmax)

Secondary outcomes

  1. The total clearance(CL)

    Time frame: 150 days

    Evaluation of the total clearance(CL)

  2. elimination half-life time(T1/2)

    Time frame: 150 days

    Evaluation of elimination half-life time(T1/2)

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

Pharmacokinetic Study of Recombinant Monoclonal Antibody Against Human Epidermal Growth Factor Receptor Injection (HS627) and Perjeta ® in Healthy Male Subjects: a Randomized, Double-blind, Parallelity-controlled Study

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 29, 2021
Registry last updated
Mar 29, 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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