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

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

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Key information

Conditions

Healthy Participants

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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 criteria

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