Early Phase 1 Transverse Myelitis Trial, Recruiting NCT05145361 Sponsor: Shanghai Pharmaceuticals Holding Co., Ltd Condition: Transverse Myelitis
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Early Phase 1 Transverse Myelitis Trial, Recruiting

NCT05145361
Recruiting Early 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 have been diagnosed with a condition called NMOSD (Neuromyelitis Optica Spectrum Disorder) and have tested positive for a specific antibody called anti-AQP4 in a screening blood test.
  • You have had at least 1 documented relapse (a flare-up of symptoms) in the 12 months before joining the study.
  • Your level of disability, as measured by a standard neurological scale, falls within a certain range — from no disability to moderate-to-severe disability (confirm with trial site).
  • You are between 18 and 70 years old at the time you give your consent to join.

Who may not be able to join:

  • You have received certain medications used to treat MS or similar conditions (such as natalizumab, fingolimod, or others) within the 6 months before the study starts.
  • You have taken certain immune-suppressing drugs or biological treatments (such as azathioprine, methotrexate, or tocilizumab) within 3 months before the first dose of the study treatment.
  • You have another serious uncontrolled illness, such as a heart condition, blood disorder, lung disease, kidney disease, or a severe immune deficiency.
  • You have had a known active infection within 3 months before the study starts.
  • You are currently pregnant or breastfeeding.
  • You have had a severe allergic reaction to a biological medicine in the past.
  • You have chronic active hepatitis B or hepatitis C.
  • You have active tuberculosis (TB).
  • Your blood test results at screening show abnormal levels of certain blood cells or liver-related markers (confirm with trial site).
  • You have had a problem with drug or alcohol misuse within the 6 months before the study starts.
  • You have received a live vaccine within 4 weeks before the study starts.
  • You have uncontrolled high blood pressure, diabetes, or other uncontrolled ongoing health conditions.

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 28 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Fu-Dong Shi, MD,PhD, Tianjin Medical University General Hospital

Phone: 022-60814587

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
Early Phase 1
Sponsor
Shanghai Pharmaceuticals Holding Co., Ltd
Registry
ClinicalTrials.gov
Start date
7 April 2022
Est. completion
15 December 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Dose-limiting toxicity (DLT); Evaluate incidence of treatment-emergent adverse events [Safety and Tolerability].

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: 28 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