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Health VolunteerPhase 1NCT06732973

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

A Phase 1 study testing JS005 in people with Health Volunteer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 49 yearsHealthy volunteers can take part
Conditions the study is for
Health Volunteer
What is being tested?
JS005
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
272 participants
Where
1 siteChina
Study dates
20 Dec 2024to 21 Oct 2025
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 49 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 18Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Zhengzhou Sixth People's Hospital

    Zhengzhou, Henan, 450015

Other trials in China

About this study

Official title: A Randomized, Open- Label, Parallel Controlled Study to Compare the Pharmacokinetics of JS005 With a Pre-filled Syringe and a Pre-filled Automatic Syringe Subcutaneously Injected in Healthy Volunteers

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.

Being tested
JS005

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • JS005Drug

    JS005：The drug was administered by a single subcutaneous injection

Study groups in NCT06732973
Study groupRoleWhat they receive
Experimental：JS005 AIExperimentalThe drug was administered by a single subcutaneous injection via AI
Receives: Drug: JS005
Experimental：JS005 PFSActive comparatorThe drug was administered by a single subcutaneous injection via PFS
Receives: Drug: JS005

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC0-last

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

    Measured: 85 days

  2. Cmax

    Maximum Concentration

    Measured: 85 days

  3. AUC0-inf

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

    Measured: 85 days

Secondary outcomes (8)

  1. incidence and severity of adverse events(AE)

    incidence and severity of adverse events(AE)

    Measured: 85 days

  2. The time to reach Cmax （Tmax）

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

    Measured: 85 days

  3. Apparent clearance(CL/F)

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

    Measured: 85 days

  4. T1/2

    Elimination half-life of JS005

    Measured: 85 days

  5. Vz/F

    Apparent volume of distribution of JS005

    Measured: 85 days

  6. ADA

    Incidence of anti-JS005 drug antibodies (ADA)

    Measured: 85 days

  7. ADA-positive

    Titers of ADA-positive samples

    Measured: 85 days

  8. NAb

    Incidence of neutralizing antibodies (NAb)

    Measured: 85 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2024
  2. Study start20 Dec 2024
  3. Primary completion6 Jun 2025
  4. Study completion21 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
272 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06732973
Sponsor's protocol ID
JS005-007-BE
Status last verified
Dec 2025
First submitted
2 Dec 2024
Last updated
16 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing JS005 in people with Health Volunteer, run by Shanghai Junshi Bioscience Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC0-last (time frame: 85 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06732973.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.

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