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

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 \[MAD\]).

Conditions

• Alzheimer Disease

Interventions

DRUG

ADEL-Y01 - healty participants

In our Part 1 clinical trial, we plan to enroll up to 40 healthy participants, aged 18 to 65, to test the safety and tolerability of ADEL-Y01. The study is divided into 5 cohorts, each with 8 participants, where 6 receive a single dose of ADEL-Y01. Screening is done 28 days prior, followed by randomization and dosing. Participants undergo initial assessments until Day 4 and additional safety and PK evaluations over 12 weeks. Starting at 2.5 mg/kg, the ADEL-Y01 dose may increase up to 100 mg/kg based on Safety Review Committee assessments, ensuring a detailed evaluation of the drug's safety.

DRUG

Placebo - Healthy Participants

In Part 1 of our trial, we will enroll 2 placebo participants per cohort in up to 5 cohorts, undergoing the same protocol as those receiving ADEL-Y01 but with a placebo. They'll be part of the study from Day -1 to Day 4 for initial assessments and continue for 12 weeks for further safety and PK evaluations. This inclusion of placebo groups ensures a blinded study design for unbiased comparison of ADEL-Y01's safety and efficacy.

DRUG

ADEL-Y01 - MCI/AD

In Part 2 of our trial, we assess ADEL-Y01 in 33 participants aged 50 to 80 with MCI or mild AD, administering multiple IV doses every 2 weeks for 12 weeks. Each of the 3 cohorts will have 8 participants receiving ADEL-Y01, totaling 6 doses. After initial screening and consent, participants are randomized to start treatment on Day 1, with a follow-up in the clinical research unit for safety assessments. Additional safety and PK assessments occur bi-weekly up to 22 weeks, based on the start from the last dose on Day 71. Doses are set at 7.5, 20, and 50 mg/kg, adjusted based on Part 1 results and SRC safety reviews after at least 3 doses over 6 weeks. This phase focuses on understanding ADEL-Y01's safety and efficacy in AD patients through a cautious dosing strategy.

DRUG

Placebo - MCI/AD

In Part 2 of our clinical trial focusing on patients with MCI or mild AD, alongside the active treatment groups, we plan to include placebo groups within the 3 cohorts. Out of the 33 participants aged 50 to 80, 3 in each cohort, totaling 9 participants, will receive a placebo instead of the active drug, ADEL-Y01, administered every 2 weeks for 12 weeks. These placebo participants undergo the same screening, consent, and randomization procedures as those receiving the active drug. They are administered the placebo following the same schedule as the active groups, ensuring a controlled and blinded study environment to accurately assess ADEL-Y01's effects without bias. Placebo participants are crucial for comparing the active drug's impact on safety, tolerability, and effectiveness against a non-therapeutic intervention, maintaining the study's integrity and providing a benchmark for evaluating ADEL-Y01's true pharmacological effects on MCI or mild AD conditions.

Sponsors & Collaborators

• Oscotec Inc.

  collaborator INDUSTRY

• Alzheimer's Disease Expert Lab (ADEL), Inc.

  lead INDUSTRY

Principal Investigators

• Seung-Yong Yoon · Alzheimer's Disease Expert Lab (ADEL), Inc.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-02-06

Primary Completion

2026-01-07

Completion

2026-01-07

FDA Drug

Yes

Countries

• United States

Study Locations