RecruitingEarly Phase 1NCT07577817

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.

Enrollment

72 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Chronic Kidney Disease Iron Deficiencies Anemia

Summary

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called CTX001 Multiple Dose, a drug called CTX001 With Iron, and others for people with anemia, chronic kidney disease, and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 55 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCTX001 With and Without Iron

There are two treatment periods. In the first, CTX001 is administered as a single dose (tablet) by itself. In the second, CTX001 is administered as a single dose (tablet) with iron.

DRUGCTX001 With Iron

There are two treatment periods. In one, CTX001 is administered as a single dose (tablet) with iron (tablet) following a high fat, high calorie meal. In the other, CTX001 is administered as a single dose (tablet) with iron (tablet) under fasting conditions.

DRUGCTX001 Multiple Dose

CTX001 (tablet) is administered daily for 7 consecutive days.

DRUGPlacebo With and Without Iron

There are two treatment periods. In the first, placebo is administered as a single dose (tablet) by itself. In the second, placebo is administered as a single dose (tablet) with iron.

DRUGPlacebo With Iron

There are two treatment periods. In one, placebo is administered as a single dose (tablet) with iron (tablet) following a high fat, high calorie meal. In the other, placebo is administered as a single dose (tablet) with iron (tablet) under fasting conditions.

DRUGPlacebo Multiple Dose

Placebo (tablet) is administered daily for 7 consecutive days.