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

Phase 1

Completed

• Conditions: Healthy Participants
• Interventions: Drug: HZBio1 0.96mg / kg; Drug: HZBio1 3mg / kg; Drug: HZBio1 6mg / kg; Drug: HZBio1 9mg / kg; Drug: HZBio1 12mg / kg; Drug: Placebo

• Registration Number: NCT04765995
• Lead Sponsor: Hangzhou Grand Biologic Pharmaceutical, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-02-18
• Study First Posted: 2021-02-23
• Study Start: 2021-03-01
• Primary Completion: 2021-10-31
• Study Completion: 2022-01-14
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HZBio1 0.96mg/kg	Placebo	Participants will receive intramuscularly 0.96 milligram per kilogram (mg/kg) of HZBio1.
HZBio1 0.96mg/kg	HZBio1 0.96mg / kg	Participants will receive intramuscularly 0.96 milligram per kilogram (mg/kg) of HZBio1.
HZBio1 3mg/kg	Placebo	Participants will receive intramuscularly 3 milligram per kilogram (mg/kg) of HZBio1.
HZBio1 12mg/kg	Placebo	Participants will receive intramuscularly 12 milligram per kilogram (mg/kg) of HZBio1.
HZBio1 6mg/kg	Placebo	Participants will receive intramuscularly 6 milligram per kilogram (mg/kg) of HZBio1.
HZBio1 3mg/kg	HZBio1 3mg / kg	Participants will receive intramuscularly 3 milligram per kilogram (mg/kg) of HZBio1.
HZBio1 6mg/kg	HZBio1 6mg / kg	Participants will receive intramuscularly 6 milligram per kilogram (mg/kg) of HZBio1.
HZBio1 9mg/kg	HZBio1 9mg / kg	Participants will receive intramuscularly 9milligram per kilogram (mg/kg) of HZBio1.
HZBio1 9mg/kg	Placebo	Participants will receive intramuscularly 9milligram per kilogram (mg/kg) of HZBio1.
HZBio1 12mg/kg	HZBio1 12mg / kg	Participants will receive intramuscularly 12 milligram per kilogram (mg/kg) of HZBio1.

Primary Outcome Measures

Name	Time	Method
Tmax of HZBio1	36 days	Time to peak (Tmax)
Cmax of HZBio1	36 days	peak concentration (Cmax)
Кel of HZBio1	36 days	Кel of HZBio1 (elimination constant)
Percentage of Participants With Adverse Events (AEs)	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.
Number of anti PHC antibody	36 days	The changes of anti PHC antibody were observed before and after treatment.
serum uric acid level	36 days	The decrease of serum uric acid level after administration will be analyzed.
Number of Participants Positive for Nab（Neutralizing Antibody）	36 days	The changes of neutralizing antibody were observed before and after treatment.
Number of anti peg antibody	36 days	The changes of anti peg antibody were observed before and after treatment.
Т1/2 of HZBio1	36 days	Т1/2 of HZBio1 (half-life)
AUC0-t of HZBio1	36 days	AUC0-t of HZBio1 (the area under the Concentration vs. Time curve from 0 to t post-infusion)

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Peking, China