A Comparative Pharmacokinetic Study to Evaluate Different Manufacturing Batches of BAT1706 Injection

NCT05865574 | Unknown Phase 1

• 1 other identifier: BAT-1706-004-CR
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized, double-blind, single-dose, parallel two-arm study to compare the pharmacokinetics, safety, and immunogenicity of BAT1706 Injection from different manufacturing batches (by new process and old process) in healthy male subjects.

Conditions

Healthy Men

Outcome Measures

Primary Outcomes (5)

• AUC0-inf

  Area under the plasma concentration-time curve from zero to infinity, AUC0-∞ = AUC0-t + Ct/λz

  Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71

• AUC0-t

  Area under the blood concentration-time curve from time 0 to the last time point at which the concentration can be measured

  Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71

• Cmax

  Maximum blood concentration

  Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71

• Tmax

  Observed time to peak concentration

  Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71

• t1/2

  Elimination half-life t1/2 = 0.693/λz

  Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71

Secondary Outcomes (2)

• Adverse events

  Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71

• Immunogenicity

  Day1, 2, 3, 4, 5, 8,15, 22, 29, 36, 43, 57, 71

Study Arms (2)

BAT1706（New Process）

EXPERIMENTAL

Drug: BAT1706 1 mg/kg, the corresponding volume of bulk solution should be drawn according to the actual body weight of the subject, diluted to 100 mL with 0.9% sodium chloride solution, and administered by intravenous drip

Drug: BAT1706 Injection

BAT1706（Old Process）

ACTIVE COMPARATOR

Drug: BAT1706 1 mg/kg, the corresponding volume of bulk solution should be drawn according to the actual body weight of the subject, diluted to 100 mL with 0.9% sodium chloride solution, and administered by intravenous drip

Drug: BAT1706 Injection

Interventions

BAT1706 Injection DRUG

1 vial/carton, 400 mg/16 mL/vial

Also known as: BAT1706

BAT1706（New Process）; BAT1706（Old Process）

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male subjects aged between 18 and 45 years with body mass index (BMI) between 18.0 and 28.0 kg/m2 and body weight between 50 and 100 kg (inclusive);
• Subjects for whom the results of physical examination, vital signs, 12-lead ECG, and laboratory tests are normal or abnormal without clinical significance;
• Subjects who do not smoke, or smoke no more than 5 cigarettes per day for \< 10 years;
• Subjects who agree to use effective contraception (including but not limited to: hormonal contraception, physical contraception, or abstinence) from the time of signing the informed consent form until 6 months after intravenous drip of the study drug;
• Subjects who are willing and able to follow the visits, treatments, laboratory tests, and other relevant procedures specified in this study.

You may not qualify if:

• Subjects who have previous or current clinically significant gastrointestinal disorder (including diverticulitis, gastric ulcer), renal disorder, liver disorder, cardiovascular disorder, hematological disorder, lung disorder, nervous system disorder, metabolic disorder (including known diabetes mellitus), psychosis, or allergic disease (excluding mild asymptomatic seasonal allergy) at screening/enrollment, and in the opinion of the investigator, are not suitable for participation in this clinical study;
• Subjects who have psychiatric disorders, or in the opinion of the investigator, are not suitable for participation in this clinical study (e.g., he is considered unable to understand or follow the relevant requirements of the study, or some of his existing conditions may result in additional risks associated with participation in this study);
• Subjects who have previous or current clinically significant allergies (excluding mild asymptomatic seasonal allergy); or subjects who have known or suspected allergy or hypersensitivity to any component of the study drug; or subjects who have known or suspected hypersensitivity to Chinese hamster ovary cell products or other recombinant human or humanized antibodies;
• Subjects who have a tendency to haemorrhage or thrombosis, or have a history of non-traumatic haemorrhage with appropriate clinical treatment, or have a history of thrombosis, or have any disease that may increase the risk of haemorrhage or thrombosis (e.g., abnormal coagulation, thrombocytopenia, or INR \> 1.5);
• Subjects who have any previous malignancy including lymphoma, leukemia, and skin cancer;
• Subjects who have abnormal and clinically significant ECG (as judged by the investigator), or corrected QT interval according to Bazett's formula \> 470 ms (Bazett's formula: Q-Tc = QT/(R-R)0.5, where R-R represents the interval between two R waves in s);
• Subjects who have a history of hypertension, or systolic blood pressure \> 145 mmHg or diastolic blood pressure \> 95 mmHg at screening/enrollment;
• Subjects who have clinically significant chronic or acute infection at screening/enrollment; or have any positive result for HBV surface antigen, HCV antibody, HIV antibody, and treponema pallidum antibody at screening;
• Subjects who have previously used Bevacizumab or VEGF-targeting agents;
• Subjects who have used any biological product within 3 months prior to enrollment, or have used any monoclonal antibody within 9 months prior to enrollment;
• Subjects who have used prescription or over-the-counter drugs within 14 days prior to enrollment, or less than 5 half-lives have passed from the last dose to the dosing day of this study, whichever is longer;
• Subjects who have used any Chinese herbal medicine within 14 days prior to enrollment;
• Subjects who have participated in other drug clinical trials within 3 months prior to enrollment, or propose to participate in other drug clinical trials during this study;
• Subjects who have received live virus vaccine within 12 weeks prior to screening, or plan to receive live virus vaccine during the study;
• Subjects who have undergone major injury, surgery, or fracture within 4 weeks prior to enrollment, or propose to undergo surgery during the study;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Study Officials

• Wei Hu, Ph.D

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenting Li

CONTACT

15812648239; wtli1@bio-thera.com

Zhaohe Wang, Ph.D

CONTACT

Study Design

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

Study Record Dates

• First Submitted: April 28, 2023
• First Posted: May 19, 2023
• Study Start: June 1, 2023
• Primary Completion: September 1, 2023
• Study Completion: January 1, 2024
• Last Updated: May 19, 2023

Record last verified: 2023-03

Locations

CN (1)