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

Sponsor
Cajal Therapeutics Inc.
Study ID
NCT07577817
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

  • CTX001 With and Without Iron — DRUG
    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.
  • CTX001 With Iron — DRUG
    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.
  • CTX001 Multiple Dose — DRUG
    CTX001 (tablet) is administered daily for 7 consecutive days.
  • Placebo With and Without Iron — DRUG
    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.
  • Placebo With Iron — DRUG
    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.
  • Placebo Multiple Dose — DRUG
    Placebo (tablet) is administered daily for 7 consecutive days.

Study Details

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.

Key Dates

First listed
May 11, 2026
Start date
Jun 30, 2026
Status verified
May 2026
Primary completion
Oct 31, 2026
Completion
Dec 30, 2026

Study Design

Enrollment
72 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Single Ascending Dose (CTX001)
    Up to 5 sequential, single ascending dose cohorts.
  • Placebo Comparator: Single Ascending Dose (Placebo)
    Up to 5 sequential, single ascending dose cohorts
  • Experimental: Food Effect (CTX001)
    Up to 3 sequential, single ascending dose food effect cohorts
  • Placebo Comparator: Food Effect (Placebo)
    Up to 3 sequential, single ascending dose food effect cohorts
  • Experimental: Multiple Ascending Dose (CTX001)
    Up to 3 multiple ascending dose cohorts.
  • Placebo Comparator: Multiple Ascending Dose (Placebo)
    Up to 3 multiple ascending dose cohorts

Primary Outcome Measure

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [ Time Frame: From first dose of study drug through the last study visit, approximately 15 days. ]

Central Contacts

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