Comparative Study to Evaluate the Pharmacokinetics of BAT2306 vs Cosentyx® in Healthy Subjects

A Randomized, Double-blinded, Single-dose, 3-arms Parallel, Comparative Study to Evaluate the Pharmacokinetics and Safety of BAT2306 Injection vs Secukinumab Injection (Cosentyx®) in Healthy Chinese Male Subjects

It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2306 Injection vs Cosentyx® (EU-licensed and US-licensed) in healthy Chinese male subjects. A total of 216 healthy male subjects are planned to be included and randomized at a ratio of 1:1:1 to receive single 150mg BAT2306 Injection or Cosentyx® (EU-licensed and US-licensed).

Study Overview

• Status: Completed
• Conditions: Psoriasis
• Intervention / Treatment: Drug: BAT2306; Drug: Cosentyx (US-licensed); Drug: Cosentyx (EU-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 Secukinumab, 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.

• Study Type: Interventional
• Enrollment (Actual): 216
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Jilin
    • Changchun, Jilin, China
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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 (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, tumor, pulmonary, immune, mental or cardiovascular and cerebrovascular 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 Secukinumab (or its biosimilars) or interleukin (IL-17) targeting agents, or having used any biological products or monoclonal antibodies within 3 months before screening (or within 5 half-lives of the drugs, whichever is longer);
• Having received within 12 weeks prior to initiating treatment or planning to receive live vaccines during the study;
• Suspected or confirmed as allergic constitution (allergic to variety of drugs or food), or allergic to Secukinumab, 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;
• Positive urine drug screening or drug abuse history or drug use in the past five years;
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BAT2306 injection; 150mg /1ml; subcutaneous injection	Drug: BAT2306; 150mg/1 ml; single dose；prefilled syringe; subcutaneous injection
Active Comparator: Cosentyx (US-licensed); 150mg /1ml; subcutaneous injection	Drug: Cosentyx (US-licensed); 150mg/1 ml; single dose；prefilled syringe; subcutaneous injection; Other Names: Secukinumab
Active Comparator: Cosentyx (EU-licensed); 150mg /1ml; subcutaneous injection	Drug: Cosentyx (EU-licensed); 150mg/1 ml; single dose；prefilled syringe; subcutaneous injection; Other Names: Secukinumab

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics Endpoint：Peak plasma concentration (Cmax)	Pharmacokinetics Endpoint：Peak plasma concentration (Cmax)	0-5months
Pharmacokinetics Endpoint：Area under the plasma concentration versus time curve (AUC0-inf)	Pharmacokinetics Endpoint：Area under the plasma concentration versus time	0-5months

Collaborators and Investigators

• Sponsor: Bio-Thera Solutions
• Investigators: Principal Investigator: Yanhua Ding, The First Hospital of Jinlin University

Study record dates

Study Major Dates

• Study Start (Actual): June 8, 2022
• Primary Completion (Actual): May 3, 2023
• Study Completion (Actual): June 5, 2023

Study Registration Dates

• First Submitted: January 12, 2021
• First Submitted That Met QC Criteria: January 13, 2021
• First Posted (Actual): January 15, 2021

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis; Physiological Effects of Drugs; Immunologic Factors; Antibodies, Monoclonal
• Other Study ID Numbers: BAT-2306-001-CR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Only one site study

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No