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Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 1

Locations

China

Study Type

Interventional

Intervention

BAT2206

Stelara(US-licensed)

Stelara(EU-licensed)

About this trial

This is an interventional treatment trial for Psoriasis

Eligibility Criteria

18 Years - 55 Years (Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

Chinese male healthy subjects aged from 18 to 55 years (including the boundary value)；
BMI between 18-28kg/m2 (including boundary value) and body weight between 55-85kg;
Normal physical examination results or abnormal with no clinical significance according to the doctor's judgment;
The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period and within 6 months after the completion of the study, and voluntarily adopts effective contraceptive measures;
Sign the informed consent before joining the study, and fully understand the content, process and possible risks;
Willing and able to comply with the visits and treatments of the trial protocol.

Exclusion Criteria:

Clinical laboratory examination results are abnormal and with clinical significance, or other clinical findings indicate diseases with clinical significance within one year prior to screening;
ECG is abnormal and has clinical significance (judged by the investigator);
With active infection within two months before screening, including acute and chronic infection and local infection;
Hepatitis B and/or Hepatitis C; or HIV antigen/antibody positive; or Treponema pallidum antibody positive;
Having taken any prescription drug, over-the-counter drug, any vitamin product or herbal medicine within 28 days before screening (or within 5 half-lives of the above drugs, whichever is longer);
Having participated in drug clinical trials within 3 months before the study administration, or planning to participate in other drug clinical trials during the study period;
Acute disease occurred or with concomitant medication from the screening to use of the study drug; major injury or surgery or fracture occurred within 4 weeks before enrollment, or surgery was planned during the study;
Having used ustekinumab, anti-tumor necrosis factor (TNF) or interleukin (IL) targeting agents, or having used any biological products or monoclonal antibodies within 3 months before screening;
Any immunoglobulin biologicals were used one year prior to screening;
Having received within 12 weeks prior to initiating treatment or planning to receive live virus or live vaccines during the study;
Suspected or confirmed as allergic constitution (allergic to variety of drugs or food), or allergic to ustekinumab, or severe allergic or allergic reaction to monoclonal antibody;
Blood donation or massive blood loss (> 450 ml) within 3 months before using the study drug, or planning to donate blood during the study, or having received blood transfusion within 8 weeks before screening;
Employees or relatives of all investigators, clinical centers, clinical research organizations or sponsors cannot be included in the group;
Subjects considered unsuitable by the investigators.

Sites / Locations

The First Hospital of Jilin University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

BAT2206 injection

Stelara(US-licensed)

Stelara(EU-licensed)

Arm Description

45mg; subcutaneous injection

Outcomes

Primary Outcome Measures

Pharmacokinetics Endpoint: Peak plasma concentration (Cmax)

Pharmacokinetics Endpoint: Area under the plasma concentration versus time curve (AUC0-inf)

Secondary Outcome Measures

Full Information

NCT ID

NCT04371185

First Posted

March 23, 2020

Last Updated

September 9, 2021

Sponsor

Bio-Thera Solutions

1. Study Identification

Unique Protocol Identification Number

NCT04371185

Brief Title

Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects

Official Title

A Randomized, Double-blinded, Single-dose, 3-arms Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2206 Injection vs Ustekinumab Injection (Stelara) in Healthy Chinese Male Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Completed

Study Start Date

August 8, 2020 (Actual)

Primary Completion Date

April 19, 2021 (Actual)

Study Completion Date

April 19, 2021 (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

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 BAT2206 Injection vs Stelara® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 270 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 45mg/0.5ml BAT2206 Injection or Stelara® (EU-licensed and US-licensed).

Detailed Description

The study has a screening period of 14 days. PK blood samples will be collected from subjects to determine the serum concentration of Ustekinumab, thus to evaluate the 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

Psoriasis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

270 (Actual)

8. Arms, Groups, and Interventions

Arm Title

BAT2206 injection

Arm Type

Experimental

Arm Description

45mg; subcutaneous injection

Arm Title

Stelara(US-licensed)

Arm Type

Active Comparator

Arm Description

45mg; subcutaneous injection

Arm Title

Stelara(EU-licensed)

Arm Type

Active Comparator

Arm Description

45mg; subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

BAT2206

Intervention Description

45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Stelara(US-licensed)

Other Intervention Name(s)

Ustekinumab

Intervention Description

45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

Intervention Type

Drug

Intervention Name(s)

Stelara(EU-licensed)

Other Intervention Name(s)

Ustekinumab

Intervention Description

45mg/0.5 ml; single dose；prefilled syringe; subcutaneous injection

Primary Outcome Measure Information:

Title

Pharmacokinetics Endpoint: Peak plasma concentration (Cmax)

Time Frame

0-4months

Title

Pharmacokinetics Endpoint: Area under the plasma concentration versus time curve (AUC0-inf)

Time Frame

0-4months

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: Chinese male healthy subjects aged from 18 to 55 years (including the boundary value)； BMI between 18-28kg/m2 (including boundary value) and body weight between 55-85kg; Normal physical examination results or abnormal with no clinical significance according to the doctor's judgment; The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period and within 6 months after the completion of the study, and voluntarily adopts effective contraceptive measures; Sign the informed consent before joining the study, and fully understand the content, process and possible risks; Willing and able to comply with the visits and treatments of the trial protocol. Exclusion Criteria: Clinical laboratory examination results are abnormal and with clinical significance, or other clinical findings indicate diseases with clinical significance within one year prior to screening; ECG is abnormal and has clinical significance (judged by the investigator); With active infection within two months before screening, including acute and chronic infection and local infection; Hepatitis B and/or Hepatitis C; or HIV antigen/antibody positive; or Treponema pallidum antibody positive; Having taken any prescription drug, over-the-counter drug, any vitamin product or herbal medicine within 28 days before screening (or within 5 half-lives of the above drugs, whichever is longer); Having participated in drug clinical trials within 3 months before the study administration, or planning to participate in other drug clinical trials during the study period; Acute disease occurred or with concomitant medication from the screening to use of the study drug; major injury or surgery or fracture occurred within 4 weeks before enrollment, or surgery was planned during the study; Having used ustekinumab, anti-tumor necrosis factor (TNF) or interleukin (IL) targeting agents, or having used any biological products or monoclonal antibodies within 3 months before screening; Any immunoglobulin biologicals were used one year prior to screening; Having received within 12 weeks prior to initiating treatment or planning to receive live virus or live vaccines during the study; Suspected or confirmed as allergic constitution (allergic to variety of drugs or food), or allergic to ustekinumab, or severe allergic or allergic reaction to monoclonal antibody; Blood donation or massive blood loss (> 450 ml) within 3 months before using the study drug, or planning to donate blood during the study, or having received blood transfusion within 8 weeks before screening; Employees or relatives of all investigators, clinical centers, clinical research organizations or sponsors cannot be included in the group; Subjects considered unsuitable by the investigators.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yanhua Ding

Organizational Affiliation

the First Hospital of Jinlin University

Official's Role

Principal Investigator

Facility Information:

Facility Name

The First Hospital of Jilin University

City

Jilin

Country

China

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Only one site study

Learn more about this trial

Comparative Study to Evaluate the Pharmacokinetics of BAT2206 vs Stelara® in Healthy Subjects

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