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

NCT04765995 | Completed Phase 1

• 1 other identifier: YDHY（HZBio1）-001（I）
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants

Outcome Measures

Primary Outcomes (10)

• 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

• Number of Participants Positive for Nab（Neutralizing Antibody）

  The changes of neutralizing antibody were observed before and after treatment.

  36 days

• Number of anti peg antibody

  The changes of anti peg antibody were observed before and after treatment.

  36 days

• Number of anti PHC antibody

  The changes of anti PHC antibody were observed before and after treatment.

  36 days

Study Arms (5)

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

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.

HZBio1 0.96mg/kg

HZBio1 3mg / 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.

HZBio1 3mg/kg

HZBio1 6mg / 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.

HZBio1 6mg/kg

HZBio1 9mg / 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.

HZBio1 9mg/kg

HZBio1 12mg / 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.

HZBio1 12mg/kg

Placebo DRUG

Matching placebo will be administered intramuscularly.

HZBio1 0.96mg/kg; HZBio1 12mg/kg; HZBio1 3mg/kg; HZBio1 6mg/kg; HZBio1 9mg/kg

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hangzhou Grand Biologic Pharmaceutical, Inc.: lead
• Peking Union Medical College Hospital: collaborator

Study Sites (1)

Peking Union Medical College Hospital

Beijing, China

Location

Study Officials

• Hongzhong Liu

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

• Xin Zheng

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: February 23, 2021
• Study Start: March 1, 2021
• Primary Completion: October 31, 2021
• Study Completion: January 14, 2022
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

CN (1)