Phase 1 Coeliac Disease Trial, Recruiting (NCT07377565)

Phase 1 Coeliac Disease Trial, Recruiting NCT07377565 Sponsor: Nielsen Fernandez-Becker Condition: Coeliac Disease

Printed from Voxsanity (voxsanity.com.au) — NCT07377565 — Data sourced from ClinicalTrials.gov. Verify directly with the trial site before attending. Not medical advice.

Back to Coeliac 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 are between 18 and 75 years old
You are scheduled to have a camera examination of your throat, stomach, and upper small intestine (a scope procedure) because doctors suspect you may have celiac disease
Your body weight falls within a healthy-to-moderate range for your height (BMI between 18 and 45)
Your kidney function blood test results are within an acceptable range (confirm with trial site)
Your liver function blood test results are within an acceptable range (confirm with trial site)
You are generally in good health, based on your medical history and a physical check-up
You have not taken part in any other drug trial or used an experimental medicine in the past 12 weeks
You are willing and able to follow the study instructions and sign a consent form
If you could become pregnant, or if your partner could become pregnant, you must agree to use reliable birth control throughout the study

Who may not be able to join:

You are currently pregnant, breastfeeding, planning to become pregnant, or planning to donate eggs during the study
You have a personal history of cancer of any kind
You have previously had chemotherapy or radiation treatment to the pelvic area
You have a heart condition involving the electrical rhythm of your heart, either from birth or shown on a heart tracing (confirm with trial site)
You are currently in prison, living in an institution, or are not able to make your own decisions about taking part
You have HIV, hepatitis B or C, or another significant long-term liver condition
You are currently taking medicines that suppress or reduce your immune system
You have a known allergy or sensitivity to any ingredient in the study drug
You have a history of certain bowel conditions, including eosinophilic enteritis, Crohn's disease, or ulcerative colitis

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

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: (650) 334-1308

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: NCT07377565

Sponsor: Nielsen Fernandez-Becker

Phase: Phase 1

Status: Recruiting

Condition: Coeliac Disease

Trial contact: (650) 334-1308

More information: https://clinicaltrials.gov/study/NCT07377565

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 are between 18 and 75 years old
You are scheduled to have a camera examination of your throat, stomach, and upper small intestine (a scope procedure) because doctors suspect you may have celiac disease
Your body weight falls within a healthy-to-moderate range for your height (BMI between 18 and 45)
Your kidney function blood test results are within an acceptable range (confirm with trial site)
Your liver function blood test results are within an acceptable range (confirm with trial site)
You are generally in good health, based on your medical history and a physical check-up
You have not taken part in any other drug trial or used an experimental medicine in the past 12 weeks
You are willing and able to follow the study instructions and sign a consent form
If you could become pregnant, or if your partner could become pregnant, you must agree to use reliable birth control throughout the study

Who may not be able to join:

You are currently pregnant, breastfeeding, planning to become pregnant, or planning to donate eggs during the study
You have a personal history of cancer of any kind
You have previously had chemotherapy or radiation treatment to the pelvic area
You have a heart condition involving the electrical rhythm of your heart, either from birth or shown on a heart tracing (confirm with trial site)
You are currently in prison, living in an institution, or are not able to make your own decisions about taking part
You have HIV, hepatitis B or C, or another significant long-term liver condition
You are currently taking medicines that suppress or reduce your immune system
You have a known allergy or sensitivity to any ingredient in the study drug
You have a history of certain bowel conditions, including eosinophilic enteritis, Crohn's disease, or ulcerative colitis

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 28 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

Nielsen Fernandez-Becker

Registry

ClinicalTrials.gov

Start date

29 April 2026

Est. completion

1 June 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Frequency and severity of adverse events during the study window

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