Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 Compared With EU-Phesgo®

A Randomized, Double-blind, Single Subcutaneous Administration, Parallel Control Phase I Clinical Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo® in Chinese Healthy Male Subjects.

The study is being conducted to compare the pharmacokinetic (PK) parameters of HLX319 and EU-Phesgo® after a single subcutaneous administration in healthy male subjects in China, providing a basis for the design of subsequent clinical study protocols.

Study Overview

• Status: Not yet recruiting
• Conditions: Health Adult Subjects
• Intervention / Treatment: Drug: HLX319; Drug: EU-Phesgo

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Qi Jin; Phone Number: 86 159 5516 0489; Email: Qi_jin@henlius.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230601
      • Anhui Medical University Second Affiliated Hospital
      • Contact: Wei Hu, Dr; Phone Number: 0551-65997164; Email: hwgcp@ayefy.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male subjects aged ≥18 and ≤45 years;
2. The skin at the injection site is intact, without damage, tattoos, or other markings;
3. Subjects have no history of disease or past medical history abnormalities that, in the judgment of the study physician, would affect the trial;
4. Physical examination, vital signs, chest x-ray, electrocardiogram, and laboratory investigations are normal or show abnormalities without clinical significance.
5. Body weight (BW) ≥50 and ≤75 kg;
6. Body mass index (BMI) ≥19 and ≤24 kg/m² [BMI = weight (kg) / height² (m²)];
7. Within 14 days prior to random allocation, left ventricular ejection fraction (LVEF) assessed by echocardiography is within the normal range (≥55%);

Exclusion Criteria:

1. Clinically significant diseases including but not limited to the gastrointestinal tract, kidneys, liver, nerves, blood, endocrine system, tumors, respiratory system, immune system, mental health, and cardiovascular and cerebrovascular diseases;
2. History of allergy or hypersensitivity reactions.
3. Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization;
4. History of blood donation or blood loss (>450mL) within 3 months prior to randomization;
5. Positive test results for Hepatitis B Surface Antigen (HbsAg), Hepatitis C Virus (HCV) antibodies, and Human Immunodeficiency Virus (HIV) antibodies, or abnormal and clinically significant quantitative test results for syphilis spirochetes as determined by the sub investigator;
6. History of upper respiratory tract infection or other acute infections within 2 weeks prior to r randomization;
7. History of drug abuse, substance use;
8. History of alcoholism or positive alcohol test results;

11. History of long-term heavy smoking .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HLX319 arm; subjects will receive a single subcutaneous injection of HLX319.	Drug: HLX319; HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).
Active Comparator: Eu-Phesgo arm; subjects will receive a single subcutaneous injection of Eu-Phesgo.	Drug: EU-Phesgo; EU-Phesgo is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-inf	Area-under-curve of blood drug concentration-time from time 0 to infinity after a single drug administration	up to 85 days
Cmax	Peak concentration after a single administration	up to 85 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUC0-t	Area-under-curve of the blood drug concentration-time curve from time zero to the last quantifiable concentration time	up to 85 days

Collaborators and Investigators

• Sponsor: Shanghai Henlius Biotech

Study record dates

Study Major Dates

• Study Start (Estimated): April 30, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 10, 2026

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 26, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: HLX319-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No