Clinical trial NCT04765995: Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of of HZBio1 in Healthy Subjects
Official title: A Study to Investigate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of HZBio1 in Healthy Chinese Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Lead sponsor: Hangzhou Grand Biologic Pharmaceutical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Peking Union Medical College Hospital
First posted: 2021-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Participants With Adverse Events (AEs)
timeFrame: 36 days
measure: Tmax of HZBio1
timeFrame: 36 days
measure: Cmax of HZBio1
timeFrame: 36 days
measure: Кel of HZBio1
timeFrame: 36 days
measure: Т1/2 of HZBio1
timeFrame: 36 days
measure: AUC0-t of HZBio1
timeFrame: 36 days
measure: serum uric acid level
timeFrame: 36 days
measure: Number of Participants Positive for Nab（Neutralizing Antibody）
timeFrame: 36 days
measure: Number of anti peg antibody
timeFrame: 36 days
measure: Number of anti PHC antibody
timeFrame: 36 days
Secondary outcomes:
Other outcomes:
Locations:
city: Peking
country: China
facility: Peking Union Medical College Hospital
Study officials:
affiliation: Peking Union Medical College Hospital
name: Hongzhong Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Xin Zheng
role: PRINCIPAL_INVESTIGATOR
References: