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New pill CTX001 aims to fix iron issues – first human tests begin

NCT ID NCT07577817

Knowledge-focused Sponsor: Cajal Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-stage trial tests a new drug called CTX001 in 72 healthy adults. The goal is to check for side effects and see how the drug affects iron levels in the blood, with or without iron supplements and food. It is a first step toward possibly treating anemia and iron deficiencies in people with chronic kidney disease.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
CTX001 (tablet)
What this could lead to
If successful, this could point toward a new treatment for iron-related problems in conditions like anemia and chronic kidney disease.
What could go wrong
This is a very early Phase 1 trial in only 72 healthy people, so it may not work or be safe in patients. Side effects are unknown.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 72 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Capable of giving informed consent * Agrees to use effective contraception * Body Mass Index (BMI) between 18.0 and 32.0 kg/m2 * Healthy by medical evaluation and medical history * Hematological parameters, serum iron, transferrin and ferritin are within normal range and transferrin saturation is within normal range and greater than or equal to 20% * Can swallow tablets and has suitable venous access for blood sampling Exclusion Criteria: * Has dietary requirements that may be difficult to accommodate * Is a regular user of cannabis or has a history of illicit drug abuse within 1 year * Has a history of alcohol abuse or binge drinking within 6 months * Is a regular user of tobacco or nicotine-containing products * Unwilling or unable to comply with the lifestyle guidelines described in the protocol * Has clinically significant history or evidence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, neurological, immunological, or psychiatric disorder(s) as determined by the Investigator * Has any concurrent disease or condition or physical, psychological, mental, and/or social reason that, in the opinion of the Investigator, would make the participant unsuitable for participation in the clinical study * Has received a blood transfusion within 1 year * Has donated whole blood within 6 months or plasma within 30 days * Requires prescription medication or regular use of non-prescription medication * Is an employee of the Sponsor, the CRO, or of any organization or site(s) associated with this study, or any immediate family member who is in a dependent relationship with a study site employee who is involved in the conduct of the study

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Conditions

The condition(s) this trial relates to.

anemia chronic kidney disease chronic renal failure syndrome Iron Deficiencies

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anemia Chronic kidney disease Iron deficiencies

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Nucleus Network

    RECRUITING

    Melbourne, Victoria, 3004, Australia

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