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

Sponsoren

Hauptsponsor: Hangzhou Grand Biologic Pharmaceutical, Inc.

Mitarbeiter: Peking Union Medical College Hospital

Quelle Hangzhou Grand Biologic Pharmaceutical, Inc.
Kurze Zusammenfassung

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

Gesamtstatus Not yet recruiting
Anfangsdatum March 1, 2021
Fertigstellungstermin December 31, 2021
Primäres Abschlussdatum October 31, 2021
Phase Phase 1
Studientyp Interventional
Primärer Ausgang
Messen Zeitfenster
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
Einschreibung 40
Bedingung
Intervention

Interventionsart: Drug

Interventionsname: HZBio1 0.96mg / kg

Beschreibung: 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.

Armgruppenetikett: HZBio1 0.96mg/kg

Interventionsart: Drug

Interventionsname: HZBio1 3mg / kg

Beschreibung: 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.

Armgruppenetikett: HZBio1 3mg/kg

Interventionsart: Drug

Interventionsname: HZBio1 6mg / kg

Beschreibung: 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.

Armgruppenetikett: HZBio1 6mg/kg

Interventionsart: Drug

Interventionsname: HZBio1 9mg / kg

Beschreibung: 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.

Armgruppenetikett: HZBio1 9mg/kg

Interventionsart: Drug

Interventionsname: HZBio1 12mg / kg

Beschreibung: 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.

Armgruppenetikett: HZBio1 12mg/kg

Interventionsart: Drug

Interventionsname: Placebo

Beschreibung: Matching placebo will be administered intramuscularly.

Teilnahmeberechtigung

Kriterien:

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

Geschlecht: All

Mindestalter: 18 Years

Maximales Alter: 50 Years

Gesunde Freiwillige: Accepts Healthy Volunteers

Insgesamt offiziell
Ort
Einrichtung: Kontakt: Ermittler: Peking Union Medical College Hospital Hongzhong Liu, bachelor 010-69158364 [email protected] Hongzhong Liu, bachelor Principal Investigator Xin Zheng, doctor Principal Investigator
Standort Länder

China

Überprüfungsdatum

January 2021

Verantwortliche Partei

Art: Sponsor

Hat den Zugriff erweitert No
Anzahl der Waffen 5
Armgruppe

Etikette: HZBio1 0.96mg/kg

Art: Experimental

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

Etikette: HZBio1 3mg/kg

Art: Placebo Comparator

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

Etikette: HZBio1 6mg/kg

Art: Placebo Comparator

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

Etikette: HZBio1 9mg/kg

Art: Placebo Comparator

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

Etikette: HZBio1 12mg/kg

Art: Placebo Comparator

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

Studiendesign Info

Zuweisung: Randomized

Interventionsmodell: Parallel Assignment

Hauptzweck: Treatment

Maskierung: Double (Participant, Investigator)

Quelle: ClinicalTrials.gov