Phase 1 Motor Neurone Disease Trial, Recruiting (NCT07401121)

Phase 1 Motor Neurone Disease Trial, Recruiting NCT07401121 Sponsor: Celosia Therapeutics Pty Ltd Condition: Motor Neurone Disease

Printed from Voxsanity (voxsanity.com.au) — NCT07401121 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Motor Neurone Disease

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 ALS (also known as Lou Gehrig's disease) based on specific recognised diagnostic guidelines
Your first ALS symptoms started no more than 2 years ago
You have low or no levels of a certain antibody in your blood that could interfere with the treatment (confirm with trial site)
You have been on a stable dose of your current ALS medications (such as riluzole or edaravone) and any other prescription medicines for at least 30 days before the screening visit
You are not currently pregnant or breastfeeding, or you are willing to stop breastfeeding
You are willing to use a barrier method of contraception (such as a condom) during the trial

Who may not be able to join:

You have a genetic form of ALS — for example, if you carry a specific gene change called C9ORF72 — unless your ALS is linked to a gene called TARDBP
You have had a heart attack or stroke in the last 6 months, or your diabetes is not well controlled
You have tested positive for certain infections, including cytomegalovirus, hepatitis C, hepatitis B, or HIV
Your liver, kidneys, or other organs are not functioning well enough (confirm with trial site)
You currently have a permanent breathing tube inserted through your neck (tracheostomy)

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 23 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

Australian sites

Macquarie University Hospital, Sydney, New South Wales
61298123739

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.

Voxsanity

Clinical trials and treatments, explained plainly · voxsanity.com.au

Date:

To: My Doctor

Re: Clinical trial enquiry

I am writing to enquire about the following clinical trial which may be relevant to my care:

Trial: NCT07401121

Sponsor: Celosia Therapeutics Pty Ltd

Phase: Phase 1

Status: Recruiting

Condition: Motor Neurone Disease

More information: https://clinicaltrials.gov/study/NCT07401121

Eligibility summary (AI generated)

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

You have been diagnosed with ALS (also known as Lou Gehrig's disease) based on specific recognised diagnostic guidelines
Your first ALS symptoms started no more than 2 years ago
You have low or no levels of a certain antibody in your blood that could interfere with the treatment (confirm with trial site)
You have been on a stable dose of your current ALS medications (such as riluzole or edaravone) and any other prescription medicines for at least 30 days before the screening visit
You are not currently pregnant or breastfeeding, or you are willing to stop breastfeeding
You are willing to use a barrier method of contraception (such as a condom) during the trial

Who may not be able to join:

You have a genetic form of ALS — for example, if you carry a specific gene change called C9ORF72 — unless your ALS is linked to a gene called TARDBP
You have had a heart attack or stroke in the last 6 months, or your diabetes is not well controlled
You have tested positive for certain infections, including cytomegalovirus, hepatitis C, hepatitis B, or HIV
Your liver, kidneys, or other organs are not functioning well enough (confirm with trial site)
You currently have a permanent breathing tube inserted through your neck (tracheostomy)

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

Access in Australia: A treatment being studied in a clinical trial is generally not yet listed on the PBS. Where a medicine is not approved or not available through a trial, the TGA Special Access Scheme may allow a doctor to access unapproved therapeutic goods for individual patients. See voxsanity.com.au/sas-navigator/ for a plain English explainer.

This information was sourced from ClinicalTrials.gov via Voxsanity (data last synced 23 July 2026). It is not medical advice. Please verify the trial's current status directly with the trial site before acting.

Trial details

Status

Recruiting

Phase

Phase 1

Sponsor

Celosia Therapeutics Pty Ltd

Registry

ClinicalTrials.gov

Start date

12 January 2026

Est. completion

1 December 2027

Where this trial is recruiting

🇦🇺 Australia

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

To evaluate the safety and tolerability of CTx1000 in ALS diagnosed participants

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: 23 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