Status:
COMPLETED
Study of Pharmacokinetics, Pharmacodynamics, Safety, and Immunogenicity of of HZBio1 in Healthy Subjects
Lead Sponsor:
Hangzhou Grand Biologic Pharmaceutical, Inc.
Collaborating Sponsors:
Peking Union Medical College Hospital
Conditions:
Healthy Participants
Eligibility:
All Genders
18-50 years
Phase:
PHASE1
Brief Summary
This randomized study will evaluate the safety, tolerability ,pharmacokinetics, pharmacodynamics and Immunogenicity of single ascending intramuscularly administered doses of HZBio1 in healthy voluntee...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- 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
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 14 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04765995
Start Date
March 1 2021
End Date
January 14 2022
Last Update
May 13 2025
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, China