NCT07577817 A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.
| NCT ID | NCT07577817 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Cajal Therapeutics Inc. |
| Condition | Anemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 72 participants |
| Start Date | 2026-06 |
| Primary Completion | 2026-10 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 72 participants in total. It began in 2026-06 with a primary completion date of 2026-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Aarthy Joseph, Dr
PRINCIPAL INVESTIGATOR
Nucleus Network
Frequently Asked Questions
Who can join the NCT07577817 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Anemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07577817 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07577817 currently recruiting?
Yes, NCT07577817 is actively recruiting participants. Contact the research team at a.johnson@nucleusnetwork.com.au for enrollment information.
Where is the NCT07577817 trial being conducted?
This trial is being conducted at Melbourne, Australia.
Who is sponsoring the NCT07577817 clinical trial?
NCT07577817 is sponsored by Cajal Therapeutics Inc.. The principal investigator is Aarthy Joseph, Dr at Nucleus Network. The trial plans to enroll 72 participants.