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CompletedNCT06732973Updated Dec 16, 2025

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

A Phase 1 interventional study of JS005 in Health Volunteer, sponsored by Shanghai Junshi Bioscience Co., Ltd.. Completed at 1 site in China. Open to participants aged 18 Years to 49 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-16.

Sponsored by Shanghai Junshi Bioscience Co., Ltd. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
272
Allocation
Randomized
Ages
18 Years to 49 Years
Sex
All
01

Study summary

This study is a single-center, randomized, open-label, single-dose, parallel-controlled trial design conducted in healthy adult subjects. After signing the informed consent form and completing the screening examination, if the subjects meet all the inclusion criteria and do not meet any exclusion criteria, they will be randomly assigned to treatment group A or treatment group B: treatment group A receives a single subcutaneous injection of JS005 300 mg through PFS, and treatment group B receives a single subcutaneous injection of JS005 300 mg through AI. Subjects were followed up until the 85th day of the study to evaluate the pharmacokinetic equivalence of JS005. 136 subjects are planned to be included in each group.

The entire study cycle includes a screening period of up to 21 days and a follow-up period of 12 weeks (85 days). Subjects will be admitted to the Phase I clinical research ward on the day before administration (D-1), and can only leave after completing all examinations and evaluations on the 11th day after administration. They will return to the clinical research center for follow-up on days 15, 22, 29, 43, 57, 71, and 85.

02

Conditions studied

  • Health Volunteer
03

In context

Lead sponsor

Shanghai Junshi Bioscience Co., Ltd. is the lead sponsor of 98 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 49 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
272 participants (actual)

Study arms

  • Experimental
    Experimental:JS005 AI

    The drug was administered by a single subcutaneous injection via AI

    Drug: JS005

  • Active comparator
    Experimental:JS005 PFS

    The drug was administered by a single subcutaneous injection via PFS

    Drug: JS005

Interventions

  • DrugJS005

    JS005:The drug was administered by a single subcutaneous injection

06

What researchers measure

Primary outcomes

  1. AUC0-last

    Area under the time-concentration curve from time 0 to last time of quantifiable concentration

    Time frame: 85 days

  2. Cmax

    Maximum Concentration

    Time frame: 85 days

  3. AUC0-inf

    Area under the time-concentration curve from time 0 to inf of quantifiable concentration

    Time frame: 85 days

Secondary outcomes

  1. incidence and severity of adverse events(AE)

    incidence and severity of adverse events(AE)

    Time frame: 85 days

  2. The time to reach Cmax (Tmax)

    Pharmacokinetic (PK) parameters of JS005 :The time to receive reach Cmax (Tmax)

    Time frame: 85 days

  3. Apparent clearance(CL/F)

    Apparent clearance(CL/F) of JS005 :apparent clearance(CL/F)

    Time frame: 85 days

  4. T1/2

    Elimination half-life of JS005

    Time frame: 85 days

  5. Vz/F

    Apparent volume of distribution of JS005

    Time frame: 85 days

  6. ADA

    Incidence of anti-JS005 drug antibodies (ADA)

    Time frame: 85 days

  7. ADA-positive

    Titers of ADA-positive samples

    Time frame: 85 days

  8. NAb

    Incidence of neutralizing antibodies (NAb)

    Time frame: 85 days

07

Study locations

1 site
  • Zhengzhou Sixth People's Hospital
    Zhengzhou, Henan 450015, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 16, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06732973
Lead sponsor
Shanghai Junshi Bioscience Co., Ltd.
Collaborators
Sponsor GmbH
Responsible party
Sponsor
First posted
Dec 13, 2024
Start date
Dec 20, 2024
Primary completion
Jun 6, 2025
Completion
Oct 21, 2025
Last update
Dec 16, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.

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