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

RecruitingEARLY Phase 1Ages 18 Years - 55 YearsAllCajal Therapeutics Inc.
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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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What it tests

  • CTX001 With and Without Iron
  • CTX001 With Iron
  • CTX001 Multiple Dose
  • Placebo With and Without Iron
  • Placebo With Iron
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Where

1 site
Nucleus Network
Melbourne, Australia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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