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Search / Trial NCT06732973

A Bioequivalence Study of JS005 Pre-filled Syringe and JS005 Auto-injector

Launched by SHANGHAI JUNSHI BIOSCIENCE CO., LTD. · Dec 12, 2024

Trial Information

Current as of July 09, 2025

Not yet recruiting

Keywords

ClinConnect Summary

This clinical trial is designed to compare two ways of giving a medication called JS005, which is being tested in healthy adults. Participants will receive a single dose of JS005 either through a pre-filled syringe (PFS) or an auto-injector (AI) to see if both methods provide the same effects in the body. The study will include 136 volunteers in each group, and it will take place over a period of about 12 weeks, which includes a screening phase and multiple follow-up visits to monitor their health and how the drug works.

To participate in this study, individuals must be healthy adults aged 18 to 49 with a specific range of body weight and height. They should be willing to follow the study guidelines and use effective birth control if they are capable of becoming pregnant. Participants will spend time in a clinical research center for monitoring after receiving the injection, and they will have several scheduled follow-up visits. It’s important to note that individuals with certain health conditions, recent drug use, or specific medical histories may not be eligible to participate. If you're interested or think you might qualify, please consult with your healthcare provider for more information.

Gender

ALL

Eligibility criteria

  • Inclusion criteria:
  • Subjects voluntarily sign informed consent before any study-related procedures begin, are able to communicate smoothly with the investigator, understand and are willing to strictly comply with the clinical research protocol, study procedures, visit plans, treatment plans, laboratory tests, and other research requirements specified in the protocol.
  • Healthy male or female volunteers aged 18 to 49 (inclusive);
  • Body mass index (BMI) within the range of 18 to 26 kg/m2 (inclusive), with male weight ≥ 50kg and female weight ≥45kg.
  • Female subjects with fertility, as well as significant other male subjects of childbearing age, must be willing to use high-efficiency contraceptive methods during the study period until 20 weeks (expected 5 half-lives) after the last study drug administration (see Annex 3). Female subjects with fertility must have negative pregnancy tests during the screening period and before randomization.
  • Exclusion Criteria:
  • Previously used Secukinumab, Ixekizumab, Brodalumab, and other targeted drugs that directly act on IL-17 or IL-17 receptors.
  • Any medication used within 2 weeks before randomization or the medication used on the day of randomization is still in the elimination period (within 5 half-lives), based on the length of time (including prescription drugs, over-the-counter drugs, Chinese herbal medicines, etc.; excluding topical medication, female contraceptives, and regular vitamins);
  • Those who have participated in any clinical trial of a drug or medical apparatus within 3 months before randomization, or those who are still in the follow-up period of a clinical study or within 5 half-lives of the trial drug (whichever is longer) before randomization. Participants in clinical trials are defined as those who have given informed consent to the clinical trial and have used the trial drug (including placebo) or the trial medical apparatus.
  • Have a history of allergies to any research drug ingredients. Known allergies or hypersensitivity reactions to any biological therapy during screening, if participating in this study, will pose unacceptable risks to the subjects.
  • Individuals with clear diseases of the Central Nervous System, cardiovascular system, digestive system, respiratory system, urinary system, hematological system, endocrine and metabolic systems, etc. that require medical intervention or other diseases that are not suitable for clinical trials (such as a history of mental illness, etc.) (within 5 years before screening).
  • Those who have a history of blood donation in the past month, or have suffered severe blood loss (total blood volume ≥ 400 mL), or have received blood transfusions in the past 2 months.
  • Within the first three months of randomization, smokers and alcoholics (drinking 14 units of alcohol per week: 1 unit = 360 mL of beer, or 45 mL of Baijiu, or 150 mL of wine; smoking \> 5 cigarettes per day).
  • History of Drug Abuse, or positive urine drug screening test during the screening period;
  • Hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (Anti-HCV), Treponema pallidum antibody and acquired immunodeficiency syndrome (HIV) antibody positive;
  • The medical history, symptoms, and examination results of the subjects suggest active or latent tuberculosis. The tuberculosis status of all subjects will be screened through gamma interferon release test (IGRA) and chest X-ray.Those who test positive for IGRA will be excluded.If the IGRA result is uncertain, re-testing is allowed. Subjects with uncertain results from both tests will be excluded from the study.Subjects who underwent IGRA and X-ray examinations within one month before randomization may not undergo IGRA and X-ray examinations again during the screening period, according to the researcher's judgment.
  • Randomized individuals who have had severe trauma or undergone major surgery within the previous 6 months, or plan to undergo surgery during the trial period.
  • Screening or base line vital signs, physical examination, clinical laboratory examination \[blood routine, blood biochemistry, urine routine, coagulation function, gamma interferon release test (IGRA), blood pregnancy\], electrocardiogram examination, abdominal B-ultrasound, chest X-ray examination with abnormalities and clinical.
  • Random pre-glomerular filtration rate (eGFR) \< 90 mL/min/1.73m2
  • Random pre-alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or gamma-glutamyltransferase (GGT) exceeding 2 times ULN, or total bilirubin exceeding 1.5 times ULN
  • Those with abnormal and clinically significant results in the first 12-lead electrocardiogram (e.g. male QTcF \> 450ms, female QTcF \> 470 ms; QTcF correction calculation using Fridericia formula, Fridericia formula: QTcF = QT/(RR \^ 0.33), RR is the standardized heart rate value, obtained by dividing 60 by heart rate).
  • Pregnant or lactating women or male subjects whose spouses have pregnancy plans during the study period.
  • Subjects who have been vaccinated or exposed to any live or attenuated vaccine within the previous 6 weeks of randomization, or who are expected to receive the above vaccines during study treatment or within 8 weeks after study drug discontinuation.
  • Researchers believe that there are other factors that are not suitable for participating in the experiment.

About Shanghai Junshi Bioscience Co., Ltd.

Shanghai Junshi Bioscience Co., Ltd. is a leading biotechnology company dedicated to the research, development, and commercialization of innovative biopharmaceuticals. With a strong focus on addressing unmet medical needs, Junshi Bioscience leverages advanced technologies and a robust pipeline of therapeutic candidates, particularly in oncology and autoimmune diseases. The company is committed to rigorous clinical trials and scientific excellence, aiming to deliver transformative therapies that improve patient outcomes globally. Through strategic collaborations and a dedication to quality, Junshi Bioscience is positioned at the forefront of the biopharmaceutical industry, contributing to advancements in healthcare.

Locations

Zhengzhou, Henan, China

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported