A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-55
SponsorCajal Therapeutics Inc.
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- CTX001 With and Without Iron
- CTX001 With Iron
- CTX001 Multiple Dose
- Placebo With and Without Iron
- Placebo With Iron
- Placebo Multiple Dose
Treatment groups
72 Participants
are divided into 6 treatment groups6
Treatment groupsSee each treatment group below.
Locations
1Nucleus Network3004, MelbourneVictoria, Australia
Sponsors and collaborators
Cajal Therapeutics Inc.
Lead sponsor
Source ClinicalTrials.gov