Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of of HZBio1 in Healthy Subjects

May 8, 2025 updated by: Hangzhou Grand Biologic Pharmaceutical, Inc.

A Study to Investigate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of HZBio1 in Healthy Chinese Volunteers

This randomized study will evaluate the safety, tolerability ,pharmacokinetics, pharmacodynamics and Immunogenicity of single ascending intramuscularly administered doses of HZBio1 in healthy volunteers.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Peking, China
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Fully informed and signed informed consent form;
  2. Healthy subjects, male and female;

  3. At the time of signing the informed consent, they were over 18-45 years old (including 18 and 45 years old) and weighed more than 50 kg,

    Body mass index ranged from 19 to 26 (including 19 and 26) [body mass index (BMI) = body weight (kg) / height 2 (M2)];

  4. The results of serum pregnancy test in women of childbearing age were negative;
  5. The subjects agreed to use effective contraception or abstinence during the study period and within 6 months after the end of the study;
  6. Be able to understand and comply with the clinical protocol requirements, and it is expected to complete the whole trial process.

Exclusion Criteria:

  1. History of hypertension or abnormal blood pressure at screening / baseline (SBP > 140 mmHg and / or DBP > 90 mmHg confirmed twice a day)
  2. According to the researcher's judgment (clinical urine routine examination, proteinuria 2 + and above), proteinuria or proteinuria history with clinical significance.
  3. Any previous VEGF and VEGFR antibody or protein therapy within one year.
  4. No biological products or live virus vaccine shall be used for treatment for 3 months before the first administration of the study drug, or any monoclonal antibody shall be used for 12 months.
  5. History or evidence of hereditary bleeding, coagulopathy, or thrombosis.
  6. History of gastrointestinal perforation or fistula.
  7. Severe, unhealed wounds, active ulcers, or untreated fractures, or were randomly assigned or expected to require major surgery during the course of the study or within 2 months after the last administration of the study drug.
  8. RX or OTC drugs or nutritional supplements were used within 5 half lives before the first administration of the study drug or within 2 weeks (depending on the longer period). Herbal supplements need to be discontinued 28 days before the first administration of the study drug.
  9. HBsAg, HCV antibody, HIV antibody and syphilis were positive
  10. Known allergy to bevacizumab or any excipient
  11. Known allergic diseases or allergic constitution
  12. There was a history of unpaid blood donation within 3 months before taking the study drug for the first time
  13. Use any other study drug for treatment or participate in other clinical trials within 3 months before screening
  14. There was a history of alcohol or drug abuse within 12 months before screening; subjects were not able to control within 72 hours before and throughout the study
  15. History of mental illness
  16. During the study, the partner was expected to be pregnant.
  17. During the study period, it did not conform to the clinical study protocol.
  18. Other conditions not suitable for this study were considered by the researchers

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: HZBio1 0.96mg/kg
Participants will receive intramuscularly 0.96 milligram per kilogram (mg/kg) of HZBio1.
Drug: HZBio1 0.96mg / kg
HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.
Drug: Placebo
Matching placebo will be administered intramuscularly.
Experimental: HZBio1 3mg/kg
Participants will receive intramuscularly 3 milligram per kilogram (mg/kg) of HZBio1.
Drug: Placebo
Matching placebo will be administered intramuscularly.
Drug: HZBio1 3mg / kg
HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.
Experimental: HZBio1 6mg/kg
Participants will receive intramuscularly 6 milligram per kilogram (mg/kg) of HZBio1.
Drug: Placebo
Matching placebo will be administered intramuscularly.
Drug: HZBio1 6mg / kg
HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.
Experimental: HZBio1 9mg/kg
Participants will receive intramuscularly 9milligram per kilogram (mg/kg) of HZBio1.
Drug: Placebo
Matching placebo will be administered intramuscularly.
Drug: HZBio1 9mg / kg
HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.
Experimental: HZBio1 12mg/kg
Participants will receive intramuscularly 12 milligram per kilogram (mg/kg) of HZBio1.
Drug: Placebo
Matching placebo will be administered intramuscularly.
Drug: HZBio1 12mg / kg
HZBio1 will be administered intramuscularly in single ascending doses with starting of 0.96 mg/kg and subsequent doses of 3.0 mg/kg, 6.0 mg/kg ,9.0 mg/kg,and 12mg/kg, respectively.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Adverse Events (AEs)
Time Frame: 36 days
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
36 days
Tmax of HZBio1
Time Frame: 36 days
Time to peak (Tmax)
36 days
Cmax of HZBio1
Time Frame: 36 days
peak concentration (Cmax)
36 days
Кel of HZBio1
Time Frame: 36 days
Кel of HZBio1 (elimination constant)
36 days
Т1/2 of HZBio1
Time Frame: 36 days
Т1/2 of HZBio1 (half-life)
36 days
AUC0-t of HZBio1
Time Frame: 36 days
AUC0-t of HZBio1 (the area under the Concentration vs. Time curve from 0 to t post-infusion)
36 days
serum uric acid level
Time Frame: 36 days
The decrease of serum uric acid level after administration will be analyzed.
36 days
Number of Participants Positive for Nab（Neutralizing Antibody）
Time Frame: 36 days
The changes of neutralizing antibody were observed before and after treatment.
36 days
Number of anti peg antibody
Time Frame: 36 days
The changes of anti peg antibody were observed before and after treatment.
36 days
Number of anti PHC antibody
Time Frame: 36 days
The changes of anti PHC antibody were observed before and after treatment.
36 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hangzhou Grand Biologic Pharmaceutical, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Peking Union Medical College Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xin Zheng, Peking Union Medical College Hospital
  • Principal Investigator: Hongzhong Liu, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 14, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 12, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • YDHY（HZBio1）-001（I）

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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