Study of Pharmacokinetics, Pharmacodynamics, Safety, and... | NCT04765995

Status Module

Name	Class
Peking Union Medical College Hospital	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
HZBio1 0.96mg/kg	Experimental	Participants will receive intramuscularly 0.96 milligram per kilogram (mg/kg) of HZBio1.	Drug: HZBio1 0.96mg / kg Drug: Placebo
HZBio1 3mg/kg	Experimental	Participants will receive intramuscularly 3 milligram per kilogram (mg/kg) of HZBio1.	Drug: HZBio1 3mg / kg Drug: Placebo
HZBio1 6mg/kg	Experimental	Participants will receive intramuscularly 6 milligram per kilogram (mg/kg) of HZBio1.	Drug: HZBio1 6mg / kg Drug: Placebo
HZBio1 9mg/kg	Experimental	Participants will receive intramuscularly 9milligram per kilogram (mg/kg) of HZBio1.	Drug: HZBio1 9mg / kg Drug: Placebo
HZBio1 12mg/kg	Experimental	Participants will receive intramuscularly 12 milligram per kilogram (mg/kg) of HZBio1.	Drug: HZBio1 12mg / kg Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HZBio1 0.96mg / kg	Drug	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	36 days
Tmax of HZBio1	Time to peak (Tmax)	36 days
Cmax of HZBio1	peak concentration (Cmax)	36 days
Кel of HZBio1	Кel of HZBio1 (elimination constant)	36 days
Т1/2 of HZBio1	Т1/2 of HZBio1 (half-life)	36 days
AUC0-t of HZBio1	AUC0-t of HZBio1 (the area under the Concentration vs. Time curve from 0 to t post-infusion)	36 days
serum uric acid level	The decrease of serum uric acid level after administration will be analyzed.	36 days

Eligibility Module

Eligibility Criteria

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

Name	Affiliation	Role
Hongzhong Liu	Peking Union Medical College Hospital	Principal Investigator
Xin Zheng	Peking Union Medical College Hospital	Principal Investigator