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New shot for lupus enters first human tests

NCT ID NCT07323173

Disease control Sponsor: Nanjing Leads Biolabs Co.,Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 28, 2026 · Updated 2 times

Summary

This early-stage study tests a single injection of a new drug, LBL-047, in healthy adults and people with mild-to-moderate systemic lupus erythematosus (SLE). The main goal is to check safety and side effects. About 112 participants will receive either the drug or a placebo. This research helps determine if LBL-047 is safe enough for larger studies.

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

About 117 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2027

An estimate. End dates often move.

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 60 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: 1. Agree to follow the trial treatment regimen, visit schedule, laboratory test, and other requirements of the protocol, and voluntarily enroll in the study and sign the written informed consent. 2. Age 18-60 years (inclusive of boundaries) at the time of signing informed consent form. 3. Part A:Determined by the investigator to be in good health at the time of signing the ICF. 4. Part B:Mild to moderate systemic lupus erythematosus: SLEDAI-2K score ≥4 and ≤ 10 at screening. 5. Females of childbearing potential are willing to use highly effective contraception during the study and for 6 months after administration of the study drug and to avoid egg donation.Women of non-childbearing potential include: those with documented surgical sterilization or documented menopause. 6. Male of childbearing potential are willing to use highly effective contraception during the study and for 6 months after study drug administration and to avoid sperm donation.Men without fertility potential include those with: A semen sample investigation that confirms azoospermia, definitive evidence of infertility, or a history of vasoligation.For the purpose of this study, men with a "low sperm count" (or "subfertility") are not considered infertile. Exclusion Criteria: 1. Part A:Symptoms or history of any significant disease, including but not limited to cardiovascular, hepatic, renal or any other disease that may interfere with the study results. 2. Part A:Abnormalities with clinical significance were indicated by vital signs, physical examination, laboratory test, 12-lead electrocardiogram (ECG), chest X-ray, and abdominal ultrasound. 3. Part B:History of organ transplant or hematopoietic stem cell/bone marrow transplant. 4. Part B:currently receiving treatment for any chronic infection (such as pneumocystosis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteriosis). 5. Major surgery (as judged by the investigator) within 90 days prior to dosing, or surgery scheduled during the study. 6. At screening, women of childbearing potential were positive for pregnancy.follicle stimulating hormone (FSH) did not reach postmenopausal level in postmenopausal women (defined as amenorrhoea ≥ 12 months before screening). 7. Large tattoo, scar or other condition that may interfere with assessment at the injection site. 8. unable to tolerate venipuncture, difficulty in blood collection or has a history of needle/blood phobic disorder. 9. The investigator determines that there are other conditions unsuitable for participation in this study.

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Conditions

The condition(s) this trial relates to.

systemic lupus erythematosus

As listed by the trial registrant

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

Systemic lupus erythematosus

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    12 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing GoBroad Hospital

    NOT_YET_RECRUITING

    Beijing, Beijing Municipality, 102200, China

  • Mianyang Central Hospital

    RECRUITING

    Mianyang, Sichuan, 621051, China

  • Nanjing Drum Tower Hospital

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, 210008, China

  • Pingxiang People's Hospital

    RECRUITING

    Pingxiang, Jiangxi, 337099, China

  • Shanghai JiaoTong University School of Medicine，Renji Hospital

    NOT_YET_RECRUITING

    Shanghai, Shanghai Municipality, 200001, China

  • Shanghai Public Health Clinical Center

    RECRUITING

    Shanghai, Shanghai Municipality, 200083, China

  • Shanxi Bethune Hospital

    NOT_YET_RECRUITING

    Taiyuan, Shanxi, 030032, China

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    RECRUITING

    Guangzhou, Guangdong, 510120, China

  • The First Affiliated Hospital of Bengbu Medical University

    NOT_YET_RECRUITING

    Bengbu, Anhui, 233004, China

  • The Second Affiliated Hospital of Xian Jiaotong University

    RECRUITING

    Xian, Shanxi, 710004, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

  • Xiangya School of Medicine of Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, 410028, China

More trials for these conditions

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