Phase 1 Lupus Trial, Recruiting NCT07323173 Sponsor: Nanjing Leads Biolabs Co.,Ltd Condition: Lupus
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Phase 1 Lupus Trial, Recruiting

NCT07323173
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are willing to sign a consent form and are able to attend all scheduled visits and follow the study procedures.
  • You are between 18 and 60 years old at the time of signing the consent form.
  • (Part A only) You are considered to be in good general health at the time of joining, as confirmed by the study doctor.
  • (Part B only) You have mild to moderate lupus (systemic lupus erythematosus), with a disease activity score between 4 and 10 on a standard medical scale (confirm with trial site).
  • If you are a woman who could become pregnant, you are willing to use highly effective birth control during the study and for 6 months after receiving the study drug, and you agree not to donate eggs.
  • If you are a man who could father a child, you are willing to use highly effective birth control during the study and for 6 months after receiving the study drug, and you agree not to donate sperm.

Who may not be able to join:

  • (Part A only) You have a history of, or current symptoms of, any significant health condition — such as heart, liver, or kidney problems — that could affect the study results.
  • (Part A only) Your health checks (such as blood tests, heart tracing, chest X-ray, or ultrasound) show results that the study doctor considers medically significant.
  • (Part B only) You have previously had an organ transplant or a stem cell/bone marrow transplant.
  • (Part B only) You are currently being treated for an ongoing infection, such as certain viral or fungal infections (confirm with trial site for specific examples).
  • You have had a major surgery within the 90 days before starting the study, or you have surgery planned during the study period.
  • You are a woman who could become pregnant and you test positive for pregnancy at screening, or you are going through menopause but your hormone levels do not yet confirm this (confirm with trial site).
  • You have a large tattoo, scar, or skin condition in the area where the study injection would be given, which could affect how the injection site is checked.
  • You are unable to tolerate having blood drawn, have difficulty with blood collection, or have a strong fear of needles or blood.
  • The study doctor decides there is another reason that makes joining the study unsuitable for you.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: xianmin meng, Shanghai Public Health Clinical Center

Phone: 025-83378099

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Sponsor
Nanjing Leads Biolabs Co.,Ltd
Registry
ClinicalTrials.gov
Start date
16 December 2025
Est. completion
16 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Occurrence of Treatment-Emergent adverse event (TEAE) and serious adverse event (SAE)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov