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

NCT04371185 | Completed Phase 1

• 1 other identifier: BAT-2206-001-CR
• Study Type: interventional
• Target: 270
• 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 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).

Conditions

Psoriasis

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics Endpoint: Peak plasma concentration (Cmax)

  0-4months

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

  0-4months

Study Arms (3)

BAT2206 injection

EXPERIMENTAL

45mg; subcutaneous injection

Drug: BAT2206

Stelara(US-licensed)

ACTIVE COMPARATOR

45mg; subcutaneous injection

Drug: Stelara(US-licensed)

Stelara(EU-licensed)

ACTIVE COMPARATOR

45mg; subcutaneous injection

Drug: Stelara(EU-licensed)

Interventions

BAT2206 DRUG

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

BAT2206 injection

Stelara(US-licensed) DRUG

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

Also known as: Ustekinumab

Stelara(US-licensed)

Stelara(EU-licensed) DRUG

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

Also known as: Ustekinumab

Stelara(EU-licensed)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bio-Thera Solutions: lead

Study Sites (1)

The First Hospital of Jilin University

Jilin, China

Location

Related Publications (1)

• Wu M, Li X, Yang D, Wang M, Zhang H, Li C, Mai J, Yang L, Qi Y, Yu JC, Yang X, Wang Z, Gu C, Ding Y. Comparison of Pharmacokinetic Similarity, Immunogenicity, and Safety of Ustekinumab and BAT2206 in Healthy Chinese Male Subjects in a Double-Blind, Randomized, Single-Dose, Parallel-Group Phase I Trial. BioDrugs. 2023 Jan;37(1):89-98. doi: 10.1007/s40259-022-00563-5. Epub 2022 Nov 22.

  PMID: 36417156 DERIVED

MeSH Terms

Conditions

Psoriasis

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Yanhua Ding

  the First Hospital of Jinlin 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: March 23, 2020
• First Posted: May 1, 2020
• Study Start: August 8, 2020
• Primary Completion: April 19, 2021
• Study Completion: April 19, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)