Healthy volunteer study tests two injection devices for drug delivery
NCT ID NCT06732973
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether two different injection devices (a pre-filled syringe and an automatic injector) deliver the same amount of the drug JS005 into the body. It involved 272 healthy adults who received a single injection and were followed for 85 days. The goal was to see if the devices are equivalent, not to treat any disease.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- JS005
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
-
272 people
The number who actually took part.
- Started
-
Dec 2024
- Finished
-
Oct 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 49 years
- Sex
-
Anyone
- Healthy volunteers
-
Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Health volunteer are added.
Genom att skicka in godkänner du våra Användarvillkor
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Zhengzhou Sixth People's Hospital
Zhengzhou, Henan, 450015, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.