Trial · NCT07577817
A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.
NCT07577817, Early phase 1, Recruiting, Cajal Therapeutics Inc.
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults. Trials, record NCT07577817. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07577817
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CTX001 in Healthy Adults.
- NCT number
- NCT07577817
- Status
- Recruiting
- Phases
- Early phase 1
- Enrollment
- 72 participants, estimated
- Lead sponsor
- Cajal Therapeutics Inc.
- 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
- First posted
- 2026-05-11
- Last updated
- 2026-06-12
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants with Treatment-Emergent Adverse Events (TEAEs) | From first dose of study drug through the last study visit, approximately 15 days. | An adverse event (AE) is any untoward medical occurrence in a participant, whether or not considered related to the study intervention. An AE was considered a treatment-emergent AE (TEAE) if the AE started after initial study drug administration and before the last study visit. |
| Primary | Number of Participants with Serious TEAEs | From first dose of study drug through the last study visit, approximately 15 days. | A serious AE (SAE) is defined as any AE that, at any dose, meets one or more of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability or incapacity; results in a congenital anomaly or birth defect; or any important medical event that may jeopardize the participant or may require medical intervention to prevent one of the outcomes listed above. |
| Primary | Number of Participants with Clinically Significant Changes in Physical Examination | From the first dose of study drug through the last study visit; approximately 15 days. | Abnormalities in physical examinations were based on investigator's discretion. |
| Primary | Number of Participants with Clinically Significant Changes in Safety Laboratory Values | From first dose of study drug through last study visit, approximately 15 days. | Safety laboratory evaluations included blood counts, serum chemistries, coagulation studies, and urinalyses. Determination of clinical significance was based on investigator discretion. |
| Primary | Number of Participants with Clinically Significant Changes in Vital Signs | From the first dose of study drug through the last study visit, approximately 15 days. | Vital signs included heart rate, respiratory rate, blood pressure, and temperature. Determination of clinical significance was based on investigator discretion. |
| Primary | Number of Participants with Clinically Significant Changes in Electrocardiograms | From the first dose of study drug through the last study visit, approximately 15 days. | Electrocardiograms are tests that measure the electrical activity of the heart. Determination of clinical significance was based on investigator discretion. |
| Secondary | Maximum Observed Plasma Concentration (Cmax) of CTX001 | Pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours and 24 hours after the Day 1 and Day 8 doses (SAD and Food Effect Cohorts) or the Day 1 and Day 7 doses (MAD Cohorts). | |
| Secondary | Time to Maximum Observed Plasma Concentration (Tmax) of CTX001 | Pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours and 24 hours after the Day 1 and Day 8 doses (SAD and Food Effect Cohorts) or the Day 1 and Day 7 doses (MAD Cohorts). | |
| Secondary | Area Under the Curve from Time Zero Extrapolated to Infinity (AUC0-inf) of CTX001 | Pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours and 24 hours after the Day 1 and Day 8 doses (SAD and Food Effect Cohorts) or the Day 1 and Day 7 doses (MAD Cohorts). | |
| Secondary | Area Under the Curve From Time Zero to Time of Last Quantifiable Concentration (AUC0-t) of CTX001 | Pre-dose, 15 minutes, 30 minutes, 1 hour, 2 hours, 4 hours, 6 hours, 8 hours and 24 hours after the Day 1 and Day 8 doses (SAD and Food Effect Cohorts) or the Day 1 and Day 7 doses (MAD Cohorts). |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07577817
GET https://conductscience.org/api/trials/v1/NCT07577817/registered