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Healthy volunteers help test copycat drug against approved biologic

NCT ID NCT07479576

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Aug 06, 2026 · Updated 2 times

Summary

This study tests a new drug called QL2106 against an approved drug, Tremfye® (guselkumab), in 190 healthy adults aged 18-45. The goal is to compare how the body processes each drug, their safety, and immune response after a single dose. Participants receive one injection and are monitored for several months. This is a Phase 1 trial, so it focuses on safety and drug behavior, not on treating any disease.

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

190 people

The number who actually took part.

Started

Nov 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 45 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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: * Healthy subjects aged from 18 to 45 years (including the boundary value); * BMI between 19-26 kg/m2 (including boundary value) and body weight between 50-90 kg (including boundary value); * Normal results of physical examination/laboratory examination/ECG or abnormal with no clinical significance according to the PI's judgment; * The subject (including partner) has no pregnancy plan or sperm donation plan during the whole trial period and within 3 months after the completion of the drug administration and voluntarily adopts effective contraceptive measures; * Sign the informed consent before joining the study, and fully understand the content, process and possible risks. Exclusion Criteria: * History of allergic reactions or hypersensitivity to Guselkumab, other IL-23 biologics or excipients; * Alcoholics,or subjects who consumed more than 14 units of alcohol per week in the 6 months before screening; * Those who had lost blood or donated at least 400 mL in the 3 months prior to screening, or had lost blood or donated at least 200 mL in the 1 month prior to screening, or planned to donate blood during the trial; * Those who smoked more than 5 cigarettes per day in the 3 months before screening; * Drug users in the 5 years prior to screening, or positive urine drug screening; * Having used Guselkumab (or its biosimilars) or interleukin (IL-23) targeting agents; * Those who have been enrolled in other clinical studies or less than 3 months since the end of the most recent clinical study; * Use of any prescription drug, over-the-counter drug or health product within 14 days prior to screening * Any one of HBV surface antigen, HCV antibody, HIV antibody, treponema pallidum antibody positive; * Other conditions considered inappropriate to be included in this study.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Beijing GoBroad Hospital

    Beijing, Beijing Municipality, 100000, China

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