BridgeMD
Tests treatment safety and results for Anemia
Official title A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.
ClinicalTrials.gov ID: NCT07577817
What this study is testing
What is CTX001 With and Without Iron?
CTX001 With and Without Iron is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for anemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 55. Healthy volunteers may be eligible.
You may be able to join 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...
You likely can't join 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...
See the full eligibility 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
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Melbourne, Victoria, Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 55 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Melbourne, Victoria, Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.