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

Sponsors

Commanditaire principal: Hangzhou Grand Biologic Pharmaceutical, Inc.

Collaborateur: Peking Union Medical College Hospital

La source Hangzhou Grand Biologic Pharmaceutical, Inc.
Bref résumé

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

Situation globale Not yet recruiting
Date de début March 1, 2021
Date d'achèvement December 31, 2021
Date d'achèvement principale October 31, 2021
Phase Phase 1
Type d'étude Interventional
Résultat primaire
Mesure Plage de temps
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
Inscription 40
État
Intervention

Type d'intervention: Drug

Nom de l'intervention: HZBio1 0.96mg / kg

La description: 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.

Étiquette du groupe d'armements: HZBio1 0.96mg/kg

Type d'intervention: Drug

Nom de l'intervention: HZBio1 3mg / kg

La description: 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.

Étiquette du groupe d'armements: HZBio1 3mg/kg

Type d'intervention: Drug

Nom de l'intervention: HZBio1 6mg / kg

La description: 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.

Étiquette du groupe d'armements: HZBio1 6mg/kg

Type d'intervention: Drug

Nom de l'intervention: HZBio1 9mg / kg

La description: 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.

Étiquette du groupe d'armements: HZBio1 9mg/kg

Type d'intervention: Drug

Nom de l'intervention: HZBio1 12mg / kg

La description: 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.

Étiquette du groupe d'armements: HZBio1 12mg/kg

Type d'intervention: Drug

Nom de l'intervention: Placebo

La description: Matching placebo will be administered intramuscularly.

Admissibilité

Critères:

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

Le sexe: All

Âge minimum: 18 Years

Âge maximum: 50 Years

Volontaires en santé: Accepts Healthy Volunteers

Officiel général
Emplacement
Établissement: Contact: Enquêteur: Peking Union Medical College Hospital Hongzhong Liu, bachelor 010-69158364 [email protected] Hongzhong Liu, bachelor Principal Investigator Xin Zheng, doctor Principal Investigator
Pays d'implantation

China

Date de vérification

January 2021

Partie responsable

Type: Sponsor

A un accès étendu No
Nombre d'armes 5
Groupe d'armes

Étiquette: HZBio1 0.96mg/kg

Type: Experimental

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

Étiquette: HZBio1 3mg/kg

Type: Placebo Comparator

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

Étiquette: HZBio1 6mg/kg

Type: Placebo Comparator

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

Étiquette: HZBio1 9mg/kg

Type: Placebo Comparator

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

Étiquette: HZBio1 12mg/kg

Type: Placebo Comparator

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

Informations sur la conception de l'étude

Allocation: Randomized

Modèle d'intervention: Parallel Assignment

Objectif principal: Treatment

Masquage: Double (Participant, Investigator)

La source: ClinicalTrials.gov