Healthy ParticipantsPhase 1NCT04765995
Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of of HZBio1 in Healthy Subjects
A Phase 1 study testing HZBio1 0.96mg / kg, HZBio1 3mg / kg and HZBio1 6mg / kg in people with Healthy Participants, run by Hangzhou Grand Biologic Pharmaceutical, Inc. at 1 site in China.
Trial summary
This randomized study will evaluate the safety, tolerability ,pharmacokinetics, pharmacodynamics and Immunogenicity of single ascending intramuscularly administered doses of HZBio1 in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants
- What is being tested?
- HZBio1 0.96mg / kg, HZBio1 3mg / kg and HZBio1 6mg / kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2021to 14 Jan 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Fully informed and signed informed consent form;
- Healthy subjects, male and female;
- 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)];
- The results of serum pregnancy test in women of childbearing age were negative;
- The subjects agreed to use effective contraception or abstinence during the study period and within 6 months after the end of the study;
- Be able to understand and comply with the clinical protocol requirements, and it is expected to complete the whole trial process.
Who cannot join
- History of hypertension or abnormal blood pressure at screening / baseline (SBP > 140 mmHg and / or DBP > 90 mmHg confirmed twice a day)
- According to the researcher's judgment (clinical urine routine examination, proteinuria 2 + and above), proteinuria or proteinuria history with clinical significance.
- Any previous VEGF and VEGFR antibody or protein therapy within one year.
- 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.
- History or evidence of hereditary bleeding, coagulopathy, or thrombosis.
- History of gastrointestinal perforation or fistula.
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- 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.
- 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.
- HBsAg, HCV antibody, HIV antibody and syphilis were positive
- Known allergy to bevacizumab or any excipient
- Known allergic diseases or allergic constitution
- There was a history of unpaid blood donation within 3 months before taking the study drug for the first time
- Use any other study drug for treatment or participate in other clinical trials within 3 months before screening
- 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
- History of mental illness
- During the study, the partner was expected to be pregnant.
- During the study period, it did not conform to the clinical study protocol.
- Other conditions not suitable for this study were considered by the researchers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Healthy Participants
- Being tested
- HZBio1 0.96mg / kg, HZBio1 3mg / kg, HZBio1 6mg / kg, HZBio1 9mg / kg, HZBio1 12mg / kg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HZBio1 0.96mg / kgDrug
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.
HZBio1 3mg / kgDrug
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.
HZBio1 6mg / kgDrug
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.
HZBio1 9mg / kgDrug
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.
HZBio1 12mg / kgDrug
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.
PlaceboDrug
Matching placebo will be administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| HZBio1 0.96mg/kg | Experimental | Participants will receive intramuscularly 0.96 milligram per kilogram (mg/kg) of HZBio1. Receives: Drug: HZBio1 0.96mg / kg; Drug: Placebo |
| HZBio1 3mg/kg | Experimental | Participants will receive intramuscularly 3 milligram per kilogram (mg/kg) of HZBio1. Receives: Drug: HZBio1 3mg / kg; Drug: Placebo |
| HZBio1 6mg/kg | Experimental | Participants will receive intramuscularly 6 milligram per kilogram (mg/kg) of HZBio1. Receives: Drug: HZBio1 6mg / kg; Drug: Placebo |
| HZBio1 9mg/kg | Experimental | Participants will receive intramuscularly 9milligram per kilogram (mg/kg) of HZBio1. Receives: Drug: HZBio1 9mg / kg; Drug: Placebo |
| HZBio1 12mg/kg | Experimental | Participants will receive intramuscularly 12 milligram per kilogram (mg/kg) of HZBio1. Receives: Drug: HZBio1 12mg / kg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs)
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.
Measured: 36 days
Tmax of HZBio1
Time to peak (Tmax)
Measured: 36 days
Cmax of HZBio1
peak concentration (Cmax)
Measured: 36 days
Кel of HZBio1
Кel of HZBio1 (elimination constant)
Measured: 36 days
Т1/2 of HZBio1
Т1/2 of HZBio1 (half-life)
Measured: 36 days
AUC0-t of HZBio1
AUC0-t of HZBio1 (the area under the Concentration vs. Time curve from 0 to t post-infusion)
Measured: 36 days
serum uric acid level
The decrease of serum uric acid level after administration will be analyzed.
Measured: 36 days
Number of Participants Positive for Nab（Neutralizing Antibody）
The changes of neutralizing antibody were observed before and after treatment.
Measured: 36 days
Number of anti peg antibody
The changes of anti peg antibody were observed before and after treatment.
Measured: 36 days
Number of anti PHC antibody
The changes of anti PHC antibody were observed before and after treatment.
Measured: 36 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2021
- Study start1 Mar 2021
- Primary completion31 Oct 2021
- Study completion14 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hangzhou Grand Biologic Pharmaceutical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital
- Responsible party
- Sponsor
- Investigators
- Hongzhong Liu, Principal investigator, Peking Union Medical College HospitalXin Zheng, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04765995
- Sponsor's protocol ID
- YDHY（HZBio1）-001（I）
- Status last verified
- May 2025
- First submitted
- 12 Jan 2021
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liu H, Zheng X, Yang C, Tian W, Wan R, Wang Y, Yu Y, Wang Q, Wang H. Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HZBio1 in Chinese Healthy Subjects: A Randomized Phase 1a Study. Adv Ther. 2026 Sep 24. doi: 10.1007/s12325-026-03792-0. Online ahead of print.
PubMed 42782449
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Investigate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of HZBio1 in Healthy Chinese Volunteers
- ClinicalTrials.gov ID
- NCT04765995
- Acronym / sponsor ID
- YDHY（HZBio1）-001（I）
- Conditions
- Healthy Participants
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Hangzhou Grand Biologic Pharmaceutical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Peking Union Medical College Hospital
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 Oct 2021 (actual)
- Study completion
- 14 Jan 2022 (actual)
- First posted
- 23 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized study will evaluate the safety, tolerability ,pharmacokinetics, pharmacodynamics and Immunogenicity of single ascending intramuscularly administered doses of HZBio1 in healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| HZBio1 0.96mg/kg | Experimental | Drug: HZBio1 0.96mg / kg, Drug: PlaceboParticipants will receive intramuscularly 0.96 milligram per kilogram (mg/kg) of HZBio1. |
| HZBio1 3mg/kg | Experimental | Drug: HZBio1 3mg / kg, Drug: PlaceboParticipants will receive intramuscularly 3 milligram per kilogram (mg/kg) of HZBio1. |
| HZBio1 6mg/kg | Experimental | Drug: HZBio1 6mg / kg, Drug: PlaceboParticipants will receive intramuscularly 6 milligram per kilogram (mg/kg) of HZBio1. |
| HZBio1 9mg/kg | Experimental | Drug: HZBio1 9mg / kg, Drug: PlaceboParticipants will receive intramuscularly 9milligram per kilogram (mg/kg) of HZBio1. |
| HZBio1 12mg/kg | Experimental | Drug: HZBio1 12mg / kg, Drug: PlaceboParticipants will receive intramuscularly 12 milligram per kilogram (mg/kg) of HZBio1. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Fully informed and signed informed consent form;
- Healthy subjects, male and female;
- 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)];
- The results of serum pregnancy test in women of childbearing age were negative;
Key exclusion criteria (18 listed)
- History of hypertension or abnormal blood pressure at screening / baseline (SBP > 140 mmHg and / or DBP > 90 mmHg confirmed twice a day)
- According to the researcher's judgment (clinical urine routine examination, proteinuria 2 + and above), proteinuria or proteinuria history with clinical significance.
- Any previous VEGF and VEGFR antibody or protein therapy within one year.
- 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.
- History or evidence of hereditary bleeding, coagulopathy, or thrombosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HZBio1 0.96mg / kgHZBio1 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 | HZBio1 0.96mg/kg |
| HZBio1 3mg / kgHZBio1 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 | HZBio1 3mg/kg |
| HZBio1 6mg / kgHZBio1 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 | HZBio1 6mg/kg |
| HZBio1 9mg / kgHZBio1 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 | HZBio1 9mg/kg |
| HZBio1 12mg / kgHZBio1 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 | HZBio1 12mg/kg |
| PlaceboMatching placebo will be administered intramuscularly. | Drug | HZBio1 0.96mg/kg, HZBio1 12mg/kg, HZBio1 3mg/kg, HZBio1 6mg/kg, HZBio1 9mg/kg |
Primary outcome
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.
Tmax of HZBio1
Time frame: 36 days
Time to peak (Tmax)
Cmax of HZBio1
Time frame: 36 days
peak concentration (Cmax)
Кel of HZBio1
Time frame: 36 days
Кel of HZBio1 (elimination constant)
Т1/2 of HZBio1
Time frame: 36 days
Т1/2 of HZBio1 (half-life)
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)
serum uric acid level
Time frame: 36 days
The decrease of serum uric acid level after administration will be analyzed.
Number of Participants Positive for Nab（Neutralizing Antibody）
Time frame: 36 days
The changes of neutralizing antibody were observed before and after treatment.
Number of anti peg antibody
Time frame: 36 days
The changes of anti peg antibody were observed before and after treatment.
Number of anti PHC antibody
Time frame: 36 days
The changes of anti PHC antibody were observed before and after treatment.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Derived from this study: PubMed 42782449Liu H, Zheng X, Yang C, Tian W, Wan R, Wang Y, Yu Y, Wang Q, Wang H. Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of HZBio1 in Chinese Healthy Subjects: A Randomized Phase 1a Study. Adv Ther. 2026 Sep 24. doi: 10.1007/s12325-026-03792-0. Online ahead of print.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongzhong Liu principal investigator
Peking Union Medical College Hospital
Xin Zheng principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HZBio1 0.96mg / kg, HZBio1 3mg / kg and HZBio1 6mg / kg in people with Healthy Participants, run by Hangzhou Grand Biologic Pharmaceutical, Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants With Adverse Events (AEs) (time frame: 36 days). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04765995, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.