Trial · NCT06206824
Leucettinib-21 First-in-Human Phase 1 in Healthy Volunteers and Subjects With Down Syndrome and Alzheimer's Disease
NCT06206824, Phase 1, Completed, Perha Pharmaceuticals
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Leucettinib-21 First-in-Human Phase 1 in Healthy Volunteers and Subjects With Down Syndrome and Alzheimer's Disease. Trials, record NCT06206824. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06206824
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Leucettinib-21 First-in-Human Phase 1 in Healthy Volunteers and Subjects With Down Syndrome and Alzheimer's Disease
- NCT number
- NCT06206824
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 152 participants, actual
- Lead sponsor
- Perha Pharmaceuticals
- Conditions
- Healthy Volunteers, Down Syndrome, Alzheimer's Disease
- Interventions
- Leucettinib-21
- First posted
- 2024-01-16
- Last updated
- 2026-06-30
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1 : Safety and tolerability of Leucettinib-21 after single administration at 6 increasing doses in healthy male subjects. | Part 1 : Up to 8 days following administration | Assessment of systemic tolerability and safety |
| Primary | Part 2 : Effect of food on the PK parameters after an oral administration of Leucettinib-21 in healthy male subjects in high fat breakfast condition vs. under fasted conditions. | Part 2 : Up to 8 days following administration | Plasma PK assessments |
| Primary | Part 3 : Safety and tolerability of Leucettinib-21 after multiple administration at 3 increasing doses in healthy male subjects | Part 3 : Up to 21 days following administration | Assessment of systemic tolerability and safety |
| Primary | Part 4 : Safety and tolerability of Leucettinib-21 after single administration at 1 dose in Down Syndrome individuals and patients with Alzheimer's disease | Part 4 : Up to 8 days following administration | Assessment of systemic tolerability and safety |
| Primary | Part 5 : Number of participants with treatment-related adverse events after single administration of Leucettinib-21 at 2 increasing doses in healthy male and female subjects. | Part 5 : Up to 8 days following administration | Assessment of systemic tolerability and safety: * Adverse Events * Vital signs * Physical examination * ECG * Biological tests |
| Primary | Part 6 : Number of participants with treatment-related adverse events after repeated administration of Leucettinib-21 at 1 dose for 14 days in healthy male subjects | Part 6 : Up to 21 days following administration | Assessment of systemic tolerability and safety: * Adverse Events * Vital signs * Physical examination * ECG * Biological tests * Psychometric tests (REST-SPER / FOCU SHIF) * Insulin, glucagon and somatostatin dosage * NT-pro BNP and troponin |
| Secondary | PK of Leucettinib-21 | Up to 24 hours following Leucettinib-21 administration | Assessment of the plasmatic PK of Leucettinib-21 |
| Secondary | PD of Leucettinib-21 | Up to 24 hours following Leucettinib-21 administration | Change in the proteome following Leucettinib-21 administration assessed by phosphoproteomics |
| Secondary | Activity of DYRK1A | Up to 8 hours following Leucettinib-21 administration | Change in DYRK1A activity following Leucettinib-21 administration assessed in Peripheral Blood Mononuclear Cells |
Source ClinicalTrials.gov
Outcomes0
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/NCT06206824
GET https://conductscience.org/api/trials/v1/NCT06206824/registered