A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01
Public ClinicalTrials.gov record NCT06247345. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
First in Human, Phase Ia/Ib Study for Safety, Tolerability, Pharmacokinetics, and Clinical Activity Evaluation of ADEL-Y01 in Healthy Participants and in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild Alzheimer's Disease
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a Phase Ia/Ib, two-part, randomized, placebo-controlled, double-blinded, first in human(FIH) study to evaluate the safety, tolerability, PK, and PD of ADEL-Y01 in healthy participants in Part 1 and participants with MCI due to AD and mild AD in Part 2. The study includes 2 parts: Part 1 (single ascending dose \[SAD\] and Part 2 (multiple ascending dose \[MAD\]).
Study identification
- NCT ID
- NCT06247345
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 42 participants
Conditions and interventions
Conditions
Interventions
- ADEL-Y01 - healty participants Drug
- Placebo - Healthy Participants Drug
- ADEL-Y01 - MCI/AD Drug
- Placebo - MCI/AD Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 5, 2024
- Primary completion
- Jan 6, 2026
- Completion
- Jan 6, 2026
- Last update posted
- Apr 29, 2026
2024 – 2026
United States locations
- U.S. sites
- 6
- U.S. states
- 4
- U.S. cities
- 6
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| CenExel ACT | Anaheim | California | 92801 | — |
| K2 Medical Research - The Villages | Lady Lake | Florida | 32159 | — |
| K2 Medical Research - Orlando | Maitland | Florida | 32751 | — |
| Innovation Medical Research | Palmetto Bay | Florida | 33157 | — |
| Accel Research - Neurostudies | Decatur | Georgia | 30030 | — |
| Quest Research Institute | Farmington Hills | Michigan | 48334 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06247345, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 29, 2026 · Synced Sep 5, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06247345 live on ClinicalTrials.gov.