Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 55
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
72 (estimated)
Sponsor
Cajal Therapeutics Inc. · Industry
Who this trial is looking for
This trial is looking for healthy adults to test a new treatment called CTX001, which may help people with low iron levels. Participants will take the treatment and have their blood tested to see how it affects their iron levels.
Are You a Good Fit for This Trial?
You may be able to join if
I can give informed consent
I agree to use effective contraception
My BMI is between 18.0 and 32.0
I am healthy based on medical evaluation
My iron levels and related blood tests are normal
I can swallow tablets
I have suitable venous access for blood sampling
You may not be able to join if
I have special dietary requirements that are hard to manage
I use cannabis regularly or have abused drugs in the past year
I have a history of alcohol abuse or binge drinking in the past 6 months
I am a regular user of tobacco or nicotine products
I cannot follow the lifestyle guidelines in the study
I have significant health issues as determined by the study doctor
I have received a blood transfusion in the past year
I have donated whole blood in the past 6 months or plasma in the last 30 days
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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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 trans…
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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