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

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

Patrocinadores

Patrocinador principal: Hangzhou Grand Biologic Pharmaceutical, Inc.

Colaborador: Peking Union Medical College Hospital

Fuente Hangzhou Grand Biologic Pharmaceutical, Inc.
Resumen breve

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

Estado general Not yet recruiting
Fecha de inicio March 1, 2021
Fecha de Terminación December 31, 2021
Fecha de finalización primaria October 31, 2021
Fase Phase 1
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Percentage of Participants With Adverse Events (AEs) 36 days
Tmax of HZBio1 36 days
Cmax of HZBio1 36 days
Кel of HZBio1 36 days
Т1/2 of HZBio1 36 days
AUC0-t of HZBio1 36 days
serum uric acid level 36 days
Number of Participants Positive for Nab(Neutralizing Antibody) 36 days
Number of anti peg antibody 36 days
Number of anti PHC antibody 36 days
Inscripción 40
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: HZBio1 0.96mg / kg

Descripción: 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.

Etiqueta de grupo de brazo: HZBio1 0.96mg/kg

Tipo de intervención: Drug

Nombre de intervención: HZBio1 3mg / kg

Descripción: 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.

Etiqueta de grupo de brazo: HZBio1 3mg/kg

Tipo de intervención: Drug

Nombre de intervención: HZBio1 6mg / kg

Descripción: 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.

Etiqueta de grupo de brazo: HZBio1 6mg/kg

Tipo de intervención: Drug

Nombre de intervención: HZBio1 9mg / kg

Descripción: 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.

Etiqueta de grupo de brazo: HZBio1 9mg/kg

Tipo de intervención: Drug

Nombre de intervención: HZBio1 12mg / kg

Descripción: 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.

Etiqueta de grupo de brazo: HZBio1 12mg/kg

Tipo de intervención: Drug

Nombre de intervención: Placebo

Descripción: Matching placebo will be administered intramuscularly.

Elegibilidad

Criterios:

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

Género: All

Edad mínima: 18 Years

Edad máxima: 50 Years

Voluntarios Saludables: Accepts Healthy Volunteers

Oficial general
Ubicación
Instalaciones: Contacto: Investigador: Peking Union Medical College Hospital Hongzhong Liu, bachelor 010-69158364 [email protected] Hongzhong Liu, bachelor Principal Investigator Xin Zheng, doctor Principal Investigator
Ubicacion Paises

China

Fecha de verificación

January 2021

Fiesta responsable

Tipo: Sponsor

Tiene acceso ampliado No
Número de brazos 5
Grupo de brazo

Etiqueta: HZBio1 0.96mg/kg

Tipo: Experimental

Descripción: Participants will receive intramuscularly 0.96 milligram per kilogram (mg/kg) of HZBio1.

Etiqueta: HZBio1 3mg/kg

Tipo: Placebo Comparator

Descripción: Participants will receive intramuscularly 3 milligram per kilogram (mg/kg) of HZBio1.

Etiqueta: HZBio1 6mg/kg

Tipo: Placebo Comparator

Descripción: Participants will receive intramuscularly 6 milligram per kilogram (mg/kg) of HZBio1.

Etiqueta: HZBio1 9mg/kg

Tipo: Placebo Comparator

Descripción: Participants will receive intramuscularly 9milligram per kilogram (mg/kg) of HZBio1.

Etiqueta: HZBio1 12mg/kg

Tipo: Placebo Comparator

Descripción: Participants will receive intramuscularly 12 milligram per kilogram (mg/kg) of HZBio1.

Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Investigator)

Fuente: ClinicalTrials.gov