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A Phase I Study to Compare the Pharmacokinetic Characteristics, Safety, and Immunogenicity of HLX319 and EU-Phesgo®. Phase 1 24

Not yet recruiting
Clinical Trial NCT07495930 is designed to study Treatment for Health Adult Subjects. This Phase 1 interventional study is not yet recruiting. Enrollment is planned to begin on 30 April 2026 until the study accrues 24 participants. Led by Shanghai Henlius Biotech, this study is expected to complete by 10 October 2026. The latest data from ClinicalTrials.gov was last updated on 27 March 2026.
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.
Official Title

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.

Conditions
Health Adult Subjects
Other Study IDs
  • HLX319-001
NCT ID Number
NCT07495930
Start Date (Actual)
2026-04-30
Last Update Posted
2026-03-27
Completion Date (Estimated)
2026-10-10
Enrollment (Estimated)
24
Study Type
Interventional
PHASE
Phase 1
Status
Not yet recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Double
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalHLX319 arm
subjects will receive a single subcutaneous injection of HLX319.
HLX319
HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).
Active ComparatorEu-Phesgo arm
subjects will receive a single subcutaneous injection of Eu-Phesgo.
EU-Phesgo
EU-Phesgo is an original marketed drug product, with the generic name pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime 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 MeasureMeasure DescriptionTime 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
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult
Minimum Age
18 Years
Eligible Sexes
Male
Accepts Healthy Volunteers
Yes
  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%);

  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 .

Shanghai Henlius Biotech logoShanghai Henlius Biotech
Study Central Contact
Contact: qi Jin, 86 159 5516 0489, [email protected]
1 Study Locations in 1 Countries

Anhui

Anhui Medical University Second Affiliated Hospital, Hefei, Anhui, 230601, China
Wei Hu, Dr, Contact, 0551-65997164, [email protected]