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

NCT05968508 | Completed Phase 1

• 1 other identifier: BAT-1806-003-CR
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Men

Outcome Measures

Primary Outcomes (3)

• AUC0-inf

  from Day0 to Day57

• AUC0-t

  from Day0 to Day57

• Cmax

  from Day0 to Day57

Study Arms (2)

BAT1806 prefilled subcutaneous injection

EXPERIMENTAL

Drug: BAT1806 prefilled subcutaneous injection/RoActemra® (from EU)

RoActemra® (from EU)

ACTIVE COMPARATOR

Drug: BAT1806 prefilled subcutaneous injection/RoActemra® (from EU)

Interventions

BAT1806 prefilled subcutaneous injection/RoActemra® (from EU) DRUG

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.

BAT1806 prefilled subcutaneous injection; RoActemra® (from EU)

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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);
• Clinically significant (judged by investigators) abnormality in ECG, or QTcF \> 450ms (allowed to be repeated for once, the subject needs to be excluded if the two measurements of QTcF are \> 450ms);
• Acute disease or concomitant medication from screening to prior to administration of study drug;
• Positive urine drug screen, or history of drug abuse or use of narcotics in the past 5 years;
• Positive HBsAg in five hepatitis B markers at screening; or positive anti-HBc and negative anti-HBs; or positive hepatitis C antibody; or positive HIV antibody; or positive Treponema pallidum antibody;
• Intake of any alcohol-containing product within 48 hours prior to dosing of study drug, or failure to limit alcohol consumption as required during the study;

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

The Second Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Location

Related Publications (1)

• Yang Q, Jiang Y, Liu Z, Wu J, Dong Q, Liu Y, Qin H, Zhang Q, Zhang Q, Hu W. A randomized, double-blind, single-dose, parallel two-group study comparing the pharmacokinetics, safety, and immunogenicity of BAT1806 SC with tocilizumab in healthy Chinese male subjects. Expert Opin Biol Ther. 2025 Oct;25(10):1101-1111. doi: 10.1080/14712598.2025.2574006. Epub 2025 Oct 14.

  PMID: 41069221 DERIVED

MeSH Terms

Interventions

tocilizumab

Study Officials

• Wei Hu, Ph.D

  The Second Hospital of Anhui Medical University

  PRINCIPAL INVESTIGATOR

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: July 20, 2023
• First Posted: August 1, 2023
• Study Start: August 29, 2023
• Primary Completion: October 8, 2024
• Study Completion: October 8, 2024
• Last Updated: May 29, 2025

Record last verified: 2025-05

Locations

CN (1)