Comparative Study to Evaluate the Pharmacokinetics of BAT1806 vs Actemra® in Healthy Subjects

NCT03606876 | Completed Phase 1

• 1 other identifier: BAT-1806-001-CR
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT1806 Injection vs Actemra® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 138 subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed). The study has a screening period of 7 days. PK blood samples will be collected from subjects to determine the serum concentration of tocilizumab, thus to evaluate the change and similarity of the pharmacokinetics of the three study drugs. The investigator will perform safety evaluation for vital signs, physical examinations, injection site reaction, ECG, clinical laboratory tests and adverse events throughout the study. Immunogenicity evaluation (ADA, ADA titration and nAb) will also be evaluated.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics Endpoint

  AUC0-inf

  0-2months

Secondary Outcomes (2)

• Pharmacokinetics Endpoint

  0-2months

• Pharmacokinetics Endpoint

  0-2months

Study Arms (3)

BAT1806 injection

EXPERIMENTAL

BAT1806 injection: 4 mg/kg, intravenous infusion over 60 min

Drug: BAT1806 injection

Actemra(EU-licensed)

ACTIVE COMPARATOR

Actemra(EU-licensed): 4 mg/kg, intravenous infusion over 60 min

Drug: BAT1806 injection

Actemra(US-licensed)

ACTIVE COMPARATOR

Actemra(US-licensed): 4 mg/kg, intravenous infusion over 60 min

Drug: BAT1806 injection

Interventions

BAT1806 injection DRUG

Each subject will receive single intravenous drip of 4 mg/kg BAT1806 Injection or Actemra® (EU-licensed and US-licensed).

Also known as: Actemra(EU-licensed), Actemra(US-licensed)

Actemra(EU-licensed); Actemra(US-licensed); BAT1806 injection

Eligibility Criteria

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

You may qualify if:

• Signed the Inform Consent Form and fully understood the trial conduction, procedure and potential adverse reactions before entering the trial;
• Willing and able to follow the visits, treatments specified in this 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 specific contraceptive methods;
• Healthy male subjects at age of 18-55 years (inclusive for both);
• BMI between 18-28 kg/m2 (inclusive for both) and body weight between 55-85 kg (inclusive for both);
• Normal physical examinations results or abnormality without clinical significance.

You may not qualify if:

• Daily smoking amount of \>5 cigarettes within 3 months prior to the trial;
• Any current or history of severe allergic reaction to foods or drugs and History of allergy to tocilizumab or severe allergic or anaphylactic reactions to human, humanized, or murine monoclonal antibodies.
• Having a history of alcoholism (14 units of alcohol per week: 1 unit= 285 mL beer, or 25 mL spirit, or 125 mL wine);
• Having donated blood or loss of massive blood (\> 450 mL) within 3 months prior to screening, or planning to donate blood or to receive surgery during the study;
• Prior use of prescription medication, over-the-counter drugs, any vitamin products or herbs within 28 days before screening;
• Having significant changes in diet and exercise habits within 2 weeks before screening or from screening to dose;
• Having any diseases that increase the risk of bleeding, such as hemorrhoids with bleeding symptoms, acute gastritis or gastric and duodenal ulcers;
• Color Doppler echocardiography abnormalities with clinical significance;
• Having clinically significant laboratory abnormalities or other clinically indicated diseases (including but not limited to gastrointestinal, renal, liver, neurological, hematological, endocrine, tumor, lung, immune, mental or cardiovascular diseases);
• Ineligible subjects based on investigator's judgement.

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Location

Related Publications (2)

• Ebbers HC, Taylor PC, Leng X, Wei W, Kinsella NM, Zhou Y, Yang X, Chamberlain P. A Comparison of the Immunogenicity of Intravenous BAT1806, a Tocilizumab Biosimilar, and Its Reference Product. Rheumatol Ther. 2025 Jun;12(3):529-546. doi: 10.1007/s40744-025-00760-y. Epub 2025 Apr 8.

  PMID: 40198544 DERIVED

• Zhang H, Wang H, Wei H, Chen H, Liu J, Li C, Zhu X, Li X, Yu J, Zhou Y, Yang X, Wang Z, Wu M, Ding Y. A Phase I Clinical Study Comparing the Tolerance, Immunogenicity, and Pharmacokinetics of Proposed Biosimilar BAT1806 and Reference Tocilizumab in Healthy Chinese Men. Front Pharmacol. 2021 Jan 25;11:609522. doi: 10.3389/fphar.2020.609522. eCollection 2020.

  PMID: 33569002 DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

tocilizumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• yanhua ding

  The First Hospital of Jilin University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 31, 2018
• Study Start: June 13, 2018
• Primary Completion: July 17, 2019
• Study Completion: July 17, 2019
• Last Updated: November 18, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)