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Early phase 1Recruiting

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

A Phase 1, 3-Part, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Ascending Oral Doses of CTX001 in Healthy Adult Participants.

Sponsor
Cajal Therapeutics Inc. (Industry)
Enrolment
72 planned
Conditions
Anemia; Iron Deficiencies; Chronic Kidney Disease
Interventions
CTX001 With and Without Iron; CTX001 With Iron; CTX001 Multiple Dose; Placebo With and Without Iron; Placebo With Iron; Placebo Multiple Dose
Ages
adults
Registry
NCT07577817

Full record on ClinicalTrials.gov

From the registry

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.

Primary outcomes

  • Number of Participants with Treatment-Emergent Adverse Events (TEAEs)
  • Number of Participants with Serious TEAEs
  • Number of Participants with Clinically Significant Changes in Physical Examination
  • Number of Participants with Clinically Significant Changes in Safety Laboratory Values

History

  1. Study completion expected

  2. Primary completion

  3. Started

  4. Last registry update

  5. Registered