Back to results

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

Primary Purpose

Rheumatoid Arthritis

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

BAT1806 injection

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Sites / Locations

The First Bethune Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

BAT1806 injection

Actemra(EU-licensed)

Actemra(US-licensed)

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Pharmacokinetics Endpoint

AUC0-inf

Secondary Outcome Measures

Pharmacokinetics Endpoint

AUC0-t

Pharmacokinetics Endpoint

Cmax

Full Information

NCT ID

NCT03606876

First Posted

July 12, 2018

Last Updated

November 16, 2021

Sponsor

Bio-Thera Solutions

1. Study Identification

Unique Protocol Identification Number

NCT03606876

Brief Title

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

Official Title

A Randomized, Double-blinded, Single-dose, 3-arm Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT1806 Injection vs Actemra® in Healthy Chinese Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Completed

Study Start Date

June 13, 2018 (Actual)

Primary Completion Date

July 17, 2019 (Actual)

Study Completion Date

July 17, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Bio-Thera Solutions

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

138 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAT1806 injection

Arm Type

Experimental

Arm Description

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

Arm Title

Actemra(EU-licensed)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Actemra(US-licensed)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

BAT1806 injection

Other Intervention Name(s)

Actemra(EU-licensed), Actemra(US-licensed)

Intervention Description

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

Primary Outcome Measure Information:

Title

Pharmacokinetics Endpoint

Description

AUC0-inf

Time Frame

0-2months

Secondary Outcome Measure Information:

Title

Pharmacokinetics Endpoint

Description

AUC0-t

Time Frame

0-2months

Title

Pharmacokinetics Endpoint

Description

Cmax

Time Frame

0-2months

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

yanhua ding

Organizational Affiliation

The First Hospital of Jilin University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Bethune Hospital of Jilin University

City

Changchun

State/Province

Jilin

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Only one site study

Citations:

PubMed Identifier

33569002

Citation

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.

Results Reference

derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs