Pharmacokinetic Characteristics, Safety, and Immunogenici... | NCT07495930

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

NCT07495930

Sponsor

Shanghai Henlius Biotech

Status

Not yet recruiting

Last Update Posted

Apr 1, 2026Actual

Enrollment

24Estimated

Phase

Phase 1

Conditions

Health Adult Subjects

Interventions

HLX319
EU-Phesgo

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 30, 2026Estimated

Primary Completion Date

Jul 1, 2026Estimated

Completion Date

Oct 10, 2026Estimated

First Submitted Date

Mar 22, 2026

First Submission Date that Met QC Criteria

Mar 22, 2026

First Posted Date

Mar 27, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 26, 2026

Last Update Posted Date

Apr 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
HLX319	Drug	HLX319 is a biosimilar of pertuzumab-trastuzumab monoclonal antibody injection (subcutaneous injection).	HLX319 arm

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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%);

Exclusion Criteria:

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;

11. History of long-term heavy smoking .

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided