A Study to Investigate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of HZBio1 in Healthy Chinese Volunteers
Overview
- Phase
- Phase 1
- Intervention
- HZBio1 0.96mg / kg
- Conditions
- Healthy Participants
- Sponsor
- Hangzhou Grand Biologic Pharmaceutical, Inc.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Cmax of HZBio1
- Status
- Completed
- Last Updated
- 11 months ago
Overview
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.
Investigators
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
Arms & Interventions
HZBio1 0.96mg/kg
Participants will receive intramuscularly 0.96 milligram per kilogram (mg/kg) of HZBio1.
Intervention: HZBio1 0.96mg / kg
HZBio1 0.96mg/kg
Participants will receive intramuscularly 0.96 milligram per kilogram (mg/kg) of HZBio1.
Intervention: Placebo
HZBio1 3mg/kg
Participants will receive intramuscularly 3 milligram per kilogram (mg/kg) of HZBio1.
Intervention: HZBio1 3mg / kg
HZBio1 3mg/kg
Participants will receive intramuscularly 3 milligram per kilogram (mg/kg) of HZBio1.
Intervention: Placebo
HZBio1 6mg/kg
Participants will receive intramuscularly 6 milligram per kilogram (mg/kg) of HZBio1.
Intervention: HZBio1 6mg / kg
HZBio1 6mg/kg
Participants will receive intramuscularly 6 milligram per kilogram (mg/kg) of HZBio1.
Intervention: Placebo
HZBio1 9mg/kg
Participants will receive intramuscularly 9milligram per kilogram (mg/kg) of HZBio1.
Intervention: HZBio1 9mg / kg
HZBio1 9mg/kg
Participants will receive intramuscularly 9milligram per kilogram (mg/kg) of HZBio1.
Intervention: Placebo
HZBio1 12mg/kg
Participants will receive intramuscularly 12 milligram per kilogram (mg/kg) of HZBio1.
Intervention: HZBio1 12mg / kg
HZBio1 12mg/kg
Participants will receive intramuscularly 12 milligram per kilogram (mg/kg) of HZBio1.
Intervention: Placebo
Outcomes
Primary Outcomes
Cmax of HZBio1
Time Frame: 36 days
peak concentration (Cmax)
Кel of HZBio1
Time Frame: 36 days
Кel of HZBio1 (elimination constant)
Tmax of HZBio1
Time Frame: 36 days
Time to peak (Tmax)
Percentage of Participants With Adverse Events (AEs)
Time Frame: 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
Time Frame: 36 days
The changes of anti PHC antibody were observed before and after treatment.
serum uric acid level
Time Frame: 36 days
The decrease of serum uric acid level after administration will be analyzed.
Number of anti peg antibody
Time Frame: 36 days
The changes of anti peg antibody were observed before and after treatment.
Number of Participants Positive for Nab（Neutralizing Antibody）
Time Frame: 36 days
The changes of neutralizing antibody were observed before and after treatment.
Т1/2 of HZBio1
Time Frame: 36 days
Т1/2 of HZBio1 (half-life)
AUC0-t of HZBio1
Time Frame: 36 days
AUC0-t of HZBio1 (the area under the Concentration vs. Time curve from 0 to t post-infusion)