Phase 1 Motor Neurone Disease Trial, Recruiting NCT07118319 Sponsor: XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd. Condition: Motor Neurone Disease
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Phase 1 Motor Neurone Disease Trial, Recruiting

NCT07118319
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 between 18 and 75 years old (including those ages exactly)
  • You have been diagnosed with ALS (either "definite" or "probable") based on a specific set of recognised diagnostic guidelines
  • Your lung breathing capacity (measured by a breathing test called FVC) is at least 70% of the normal expected value for someone your age and size
  • If you are able to father or carry a child, you must agree to use effective non-hormonal contraception from signing the consent form until 6 months after the trial ends
  • You are willing to take part voluntarily and are able to read and sign a consent form

Who may not be able to join:

  • You have muscle weakness that may be caused by something other than ALS
  • Your body mass index (a measure of body weight relative to height) is below 18.5, meaning you may be considered underweight
  • You have a condition called primary lateral sclerosis where only the upper part of your nervous system is affected
  • You have a significant mental health condition that the doctor feels could affect the trial results
  • You have another disease affecting your nerves or muscles, such as myasthenia gravis or a metabolic muscle condition
  • You have an autoimmune disease with severe uncontrolled joint problems or other issues that the doctor feels could affect the trial results
  • You had a serious infection requiring prescription medication (antibiotics, antivirals, or antifungals) within the 2 weeks before your screening appointment, and it is not yet under control
  • You have been diagnosed with active tuberculosis (TB) or have been treated for suspected TB
  • You have a serious lung disease that the doctor feels could affect the trial results
  • You have high blood pressure that is not well controlled
  • You have had or currently have any heart problems (confirm with trial site)
  • You have a history of liver cirrhosis, long-term hepatitis, or abnormal liver function results at screening (confirm with trial site)
  • You have a history of chronic kidney disease
  • You have a history of abnormal bleeding or blood clotting, or you are currently taking blood-thinning medication
  • You tested positive at screening for active hepatitis B, active hepatitis C, HIV, or syphilis
  • You have had a serious injury or surgery that the doctor feels could affect the trial results
  • You have a condition that makes a lumbar puncture (spinal tap) unsafe for you, such as an infection near the injection site or raised pressure in your skull
  • You have had a cancer diagnosis within the past 5 years, or you are currently receiving cancer treatment
  • You have taken part in another clinical trial within the 3 months before your screening appointment
  • You are currently pregnant or breastfeeding
  • The trial doctor has another reason they feel you are not suitable for this trial (confirm with trial site)

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 21 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

Phone: +86 21 64027719

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
XellSmart Bio-Pharmaceutical (Suzhou) Co., Ltd.
Registry
ClinicalTrials.gov
Start date
15 September 2025
Est. completion
31 January 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

The incidence of XS228CN-related adverse events (AEs) and serious adverse events (SAEs) within 28 days after the last administration in ALS patients

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: 21 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