A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01 - Trial NCT06247345
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.
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Study Focus
Sponsor & Location
Alzheimer's Disease Expert Lab (ADEL), Inc.
Timeline & Enrollment
Phase 1
Jan 30, 2024
May 31, 2026
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
Data Source
ClinicalTrials.gov
NCT06247345
Non-Device Trial