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

NCT07495930 | Not Yet Recruiting Phase 1

• 1 other identifier: HLX319-001
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Health Adult Subjects

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• AUC0-t

  up to 85 days

Study Arms (2)

HLX319 arm

EXPERIMENTAL

subjects will receive a single subcutaneous injection of HLX319.

Drug: HLX319

Eu-Phesgo arm

ACTIVE COMPARATOR

subjects will receive a single subcutaneous injection of Eu-Phesgo.

Drug: EU-Phesgo

Interventions

HLX319 DRUG

HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).

HLX319 arm

EU-Phesgo DRUG

EU-Phesgo is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).

Eu-Phesgo arm

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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;
• History of allergy or hypersensitivity reactions.
• Intake of prescription drugs, over-the-counter drugs, or traditional Chinese medicine within 28 days prior to randomization;
• History of blood donation or blood loss (\>450mL) within 3 months prior to randomization;
• 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;
• History of upper respiratory tract infection or other acute infections within 2 weeks prior to r randomization;
• History of drug abuse, substance use;
• History of alcoholism or positive alcohol test results;
• \. History of long-term heavy smoking .

Sponsors & Collaborators

• Shanghai Henlius Biotech: lead

Study Sites (1)

Anhui Medical University Second Affiliated Hospital

Hefei, Anhui, 230601, China

Location

Central Study Contacts

qi Jin

CONTACT

86 159 5516 0489; Qi_jin@henlius.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: March 27, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): October 10, 2026
• Last Updated: April 1, 2026

Record last verified: 2026-03

Locations

CN (1)