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

• Sponsor: The Affiliated Hospital of Qingdao University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04820439
• Collaborator: (none)
• Enrollment: 88
• Location: 1
• Arms: 2
• Actual Duration (Months): 5
• Patients Per Site Per Month: 17.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Volunteers	Drug: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627); Drug: Perjeta ®	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 88 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official 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
• Actual Study Start Date: Oct 13, 2020
• Actual Primary Completion Date: Feb 1, 2021
• Actual Study Completion Date: Mar 13, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627)	Drug: recombinant monoclonal antibody against human epidermal growth factor receptor injection (HS627); A single intravenous infusion of HS627 420mg
Active Comparator: Perjeta ®	Drug: Perjeta ®; A single intravenous infusion of Perjeta ®420mg

Outcome Measures

Primary Outcome Measures

1. Area under the plasma concentration versus time curve (AUC)0-∞ [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 [150 days]

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

3. Peak Plasma Concentration (Cmax) [150 days]

   Evaluation of Peak Plasma Concentration (Cmax)

Secondary Outcome Measures

1. The total clearance(CL) [150 days]

   Evaluation of the total clearance(CL)

2. elimination half-life time(T1/2) [150 days]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phase I Clinical Research Center	Qingdao	Shandong	China	266003

Sponsors and Collaborators

• The Affiliated Hospital of Qingdao University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Affiliated Hospital of Qingdao University
• ClinicalTrials.gov Identifier: NCT04820439
• Other Study ID Numbers: HS627-BE
• First Posted: Mar 29, 2021
• Last Update Posted: Mar 29, 2021
• Last Verified: Mar 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pertuzumab; Antibodies; Antibodies, Monoclonal; Mitogens

Study Results

No Results Posted as of Mar 29, 2021