A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.
Recruiting · NCT07577817 · Interventional (participants receive a specific treatment) · Lead sponsor: Cajal Therapeutics Inc.
View the official record on ClinicalTrials.gov →Interventions studied
CTX001 Multiple DoseCTX001 With IronCTX001 With and Without IronPlacebo Multiple DosePlacebo With IronPlacebo With and Without Iron
What this trial is about
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.
Who can take part
Age range
18 Years to 55 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Early Phase 1
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Nucleus Network - Melbourne, Victoria, Australia