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

Healthy Participants Clinical Trial

Official title:

A Study to Investigate the Pharmacokinetics, Safety, Tolerability and Immunogenicity of HZBio1 in Healthy Chinese Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04765995
• Other study ID #: YDHY(HZBio1)-001(I)
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: March 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: January 2021
• Source: Hangzhou Grand Biologic Pharmaceutical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2021
• Est. primary completion date: October 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Participants

Intervention

Drug:
• HZBio1 0.96mg / kg
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.
• HZBio1 3mg / kg
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.
• HZBio1 6mg / kg
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.
• HZBio1 9mg / kg
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.
• HZBio1 12mg / kg
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.
• Placebo
Matching placebo will be administered intramuscularly.

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Peking

Sponsors (2)

Lead Sponsor	Collaborator
Hangzhou Grand Biologic Pharmaceutical, Inc.	Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Tmax of HZBio1	Time to peak (Tmax)	36 days
Primary	Cmax of HZBio1	peak concentration (Cmax)	36 days
Primary	?el of HZBio1	?el of HZBio1 (elimination constant)	36 days
Primary	?1/2 of HZBio1	?1/2 of HZBio1 (half-life)	36 days
Primary	AUC0-t of HZBio1	AUC0-t of HZBio1 (the area under the Concentration vs. Time curve from 0 to t post-infusion)	36 days
Primary	serum uric acid level	The decrease of serum uric acid level after administration will be analyzed.	36 days
Primary	Number of Participants Positive for Nab(Neutralizing Antibody)	The changes of neutralizing antibody were observed before and after treatment.	36 days
Primary	Number of anti peg antibody	The changes of anti peg antibody were observed before and after treatment.	36 days
Primary	Number of anti PHC antibody	The changes of anti PHC antibody were observed before and after treatment.	36 days