A Randomized, Double-blind, Single-dose, Two-arm Parallel Study to Compare the Pharmacokinetics and Safety of BAT1806 Prefilled Subcutaneous Injection With RoActemra® in Healthy Chinese Male Subjects

Bio-Thera Solutions1 site in 1 country300 target enrollmentAugust 29, 2023

ConditionsHealthy Men

InterventionsBAT1806 prefilled subcutaneous injection/RoActemra® (from EU)

DrugsBAT1806 prefilled subcutaneous injection/RoActemra® (from EU)

Overview

Phase: Phase 1
Intervention: BAT1806 prefilled subcutaneous injection/RoActemra® (from EU)
Conditions: Healthy Men
Sponsor: Bio-Thera Solutions
Enrollment: 300
Locations: 1
Primary Endpoint: AUC0-inf
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a randomized, double-blind, single-dose, two-arm parallel study to compare the pharmacokinetics, safety and immunogenicity of BAT1806 prefilled subcutaneous injection with RoActemra® (from EU) in healthy male subjects.

Detailed Description

A total of 150 subjects are planned to be enrolled and 1:1randomized to receive single dose of 162 mg/0.9 mL BAT1806 injection, or RoActemra® (from EU) subcutaneously. A 14-day screening period is set in this study. Subjects will be admitted one day prior to administration (Day -1) and can be discharged only upon completion of relevant observations and evaluations after administration on Day 5. After discharge, subjects need to return to the hospital for 10 follow-ups as required in the study.

Registry

clinicaltrials.gov

Start Date

August 29, 2023

End Date

October 8, 2024

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

Male

Investigators

Sponsor

Bio-Thera Solutions

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects can be enrolled only when they meet all the following inclusion criteria:
•Signed the informed consent form prior to the study, sufficient understanding of the content, procedure and possible adverse reactions of the study;
•Willing and able to comply with the visit and treatment specified in the study;
•Subjects (including their partners) who are willing to refrain from pregnancy, sperm donation and take effective contraceptive method in the future 6 months (i.e., 6 months after study medication), see Appendix 4 for the detailed contraceptive measures;
•Healthy male subjects aged 18～55 years (inclusive);
•BMI ranging from 18.0～28.0 kg/m2 (inclusive), and weight ranging from 55.0～85.0 kg (inclusive);
•Normal or abnormal physical examination that is judged as clinically insignificant;

Exclusion Criteria

•Subjects can not be enrolled in this study if any of the following criteria is met:
•Smoking \>5 cigarettes per day within three months prior to the study;
•Any serious allergic reaction to food or drug at present or in the past, or allergy to Tocilizumab, or serious allergy or allergic reaction to human, humanized or murine monoclonal antibody;
•History of excessive drinking (14 units of alcohol per week: 1 unit = 285 mL beer, or 25 mL liquor, or 125 mL wine);
•Blood donation or massive blood loss (\>450 mL) within three months prior to screening, or plan for blood donation or surgery during the study;
•Intake of any prescription drug, over-the-counter drug, any vitamin product or herbal medicine within 28 days prior to screening;
•Great change in dietary or exercise habit within 2 weeks prior to screening or from screening to administration;
•Having any disease that may increase hemorrhagic risk, such as haemorrhoids with hemorrhagic symptoms, acute gastritis or gastric and duodenal ulcer;
•Clinically significant abnormality in echocardiography;
•Clinically significant abnormality in clinical laboratory examination, or other clinical findings showing the following disorders of clinical relevance (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, pulmonary, immune, mental or cerebro- and cardiovascular diseases);