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NCT06247345Recruiting

A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01

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
Alzheimer's Disease Expert Lab (ADEL), Inc.Phase 1ClinicalTrials.govdrug
Verified
Study focus
Disease/Condition
Alzheimer Disease
Drug/Device/Intervention
ADEL-Y01 - healty participants
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Alzheimer's Disease Expert Lab (ADEL), Inc.
Location
Anaheim, United States of America
Timeline & enrollment
Phase
Phase 1
Start date
Jan 30, 2024
End date
May 31, 2026
Enrollment
73 participants
Primary outcome

Part 1: Evaluation of the safety and tolerability of ADEL-Y01 via single IV injection,Part 2: Assessment of safety and tolerability with multiple IV Administrations of ADEL-Y01 in participants with MCI due to AD or Mild AD

Summary

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]).

ICD-10 classifications
Alzheimer diseaseAlzheimer disease, unspecifiedOther Alzheimer diseaseDementia in Alzheimer diseaseDementia in Alzheimer disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06247345
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06247345 through Pure Global AI's free database. This Phase 1 trial is sponsored by Alzheimer's Disease Expert Lab (ADEL), Inc. and is currently Recruiting. The study focuses on Alzheimer Disease. Target enrollment is 73 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.