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

Study Purpose

It is a randomized, double-blinded, single-dose, 3-arm parallel, comparative study to evaluate the pharmacokinetics, safety and immunogenicity of BAT2306 Injection vs.#46;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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 55 Years
Gender Male
More Inclusion & Exclusion 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 (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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04711343
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Bio-Thera Solutions
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Yanhua Ding
Principal Investigator Affiliation The First Hospital of Jinlin University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Not yet recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis
Additional Details

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.

Arms & Interventions

Arms

Experimental: BAT2306 injection

150mg /1ml; subcutaneous injection

Active Comparator: Cosentyx (US-licensed)

150mg /1ml; subcutaneous injection

Active Comparator: Cosentyx (EU-licensed)

150mg /1ml; subcutaneous injection

Interventions

Drug: - BAT2306

150mg/1 ml; single dose;prefilled syringe; subcutaneous injection

Drug: - Cosentyx (US-licensed)

150mg/1 ml; single dose;prefilled syringe; subcutaneous injection

Drug: - Cosentyx (EU-licensed)

150mg/1 ml; single dose;prefilled syringe; subcutaneous injection

Contact a Trial Team

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International Sites

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

Status

Address

The First Hospital of Jilin University

Changchun, Jilin,

Site Contact

Yanhua Ding

[email protected]

86-20-38251386

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