A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.

Recruiting now · Early Phase 1 · Has a placebo group

Conditions studied: Anemia, Iron Deficiencies, Chronic Kidney Disease

In brief

This study is testing CTX001 for certain conditions where the body does not have enough available iron or has difficulty storing or moving iron properly. The purpose of this study is to investigate any side effects that may happen with CTX001, how CTX001 is absorbed by and processed in the body, and how CTX001 affects iron levels in the blood when administered with or without iron and/or food.

Key facts

Study ID

NCT07577817

Run by

Cajal Therapeutics Inc.

People needed

72

Starts

2026-06-01

Expected to finish

2026-12-30

Last updated by the study team

2026-06-12

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Nucleus Network — Melbourne, Victoria, Australia (enrolling)

Full record on ClinicalTrials.gov

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