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Virus Therapy

ADEL-Y01 for Alzheimer's Disease

Phase 1
Recruiting
Research Sponsored by Alzheimer's Disease Expert Lab (ADEL), Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy male and/or female (of nonchildbearing potential) participants aged 18 to 65 years, inclusive
Meet specific criteria for MCI due to AD or Mild AD dementia
Must not have
Males with female partners of childbearing potential who are unwilling to use double barrier method of contraception
Current active infections or recent history of active infections
Timeline
Screening 3 weeks
Treatment Varies
Follow Up d-28 ~ week 22

Summary

"This trial is testing a new drug called ADEL-Y01 in healthy participants and those with Alzheimer's disease. The study is divided into two parts, with the first part testing a single dose and the

Who is the study for?
This trial is for healthy adults aged 18-65 with a BMI of 18-30 kg/m2, who are not able to have children. Women must be postmenopausal or surgically sterile, and men must agree to use double contraception. Participants should be in good health as determined by the investigator and cannot drink alcohol before dosing.
What is being tested?
ADEL-Y01 is being tested for safety and how it's processed in the body (pharmacokinetics) in healthy people first (Part 1), then in those with mild cognitive impairment (MCI) or mild Alzheimer's Disease (AD) later (Part 2). The study compares ADEL-Y01 against a placebo, given once initially then multiple times.
What are the potential side effects?
Since this is an early-phase trial for ADEL-Y01, specific side effects aren't listed yet. Generally, participants may experience reactions related to drug administration which will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old and cannot become pregnant.
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I have been diagnosed with early-stage Alzheimer's disease.
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I weigh at least 50 kg and my BMI is between 18 and 35.
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I am between 50 and 80 years old with mild cognitive impairment due to Alzheimer's.
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I can walk on my own.
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My mental state score is between 21 and 27.
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I am using reliable birth control or am surgically sterile.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am a male unwilling to use two forms of birth control.
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I do not have any current or recent serious infections.
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I haven't donated blood or lost more than 500 mL of blood in the last 3 months.
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I have a condition that affects how drugs are broken down in my body.
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I haven't taken any medications in the last 14 days.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~d-28 ~ week 22
This trial's timeline: 3 weeks for screening, Varies for treatment, and d-28 ~ week 22 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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
Secondary study objectives
Part 1: Assessment of the exposure to ADEL-Y01 in CSF following a single IV injection
Part 1: Assessment of the immunogenicity of ADEL-Y01 following a single IV injection
Part 1: Characterization of the pharmacokinetics of ADEL-Y01 following a single IV injection
+4 more
Other study objectives
Assessment of ADEL-Y01 Effects on Biomarkers in CSF and Plasma in Participants with MCI due to AD and Mild AD for Exploratory Objective

Trial Design

16Treatment groups
Active Control
Placebo Group
Group I: SAD Cohort 2: ADEL Y-01 antibody at a dose of 7.5mg/KgActive Control1 Intervention
This arm represents the group receiving ADEL Y-01 antibody at a dose of 7.5 mg/Kg in SAD cohort 2.
Group II: MAD Cohort 2: ADEL Y-01 antibody at a dose of 20mg/KgActive Control1 Intervention
This arm represents the group receiving ADEL Y-01 antibody at a dose of 20mg/Kg in MAD cohort 2.
Group III: MAD Cohort 3: ADEL Y-01 antibody at a dose of 50mg/KgActive Control1 Intervention
This arm represents the group receiving ADEL Y-01 antibody at a dose of 50mg/Kg in MAD cohort 3.
Group IV: SAD Cohort 1: ADEL Y-01 antibody at a dose of 2.5mg/KgActive Control1 Intervention
This arm represents the group receiving ADEL Y-01 antibody at a dose of 2.5mg/Kg in SAD cohort 1.
Group V: SAD Cohort 5: ADEL Y-01 antibody at a dose of 100mg/KgActive Control1 Intervention
This arm represents the group receiving ADEL Y-01 antibody at a dose of 100mg/Kg in SAD cohort 5.
Group VI: SAD Cohort 4: ADEL Y-01 antibody at a dose of 50mg/KgActive Control1 Intervention
This arm represents the group receiving ADEL Y-01 antibody at a dose of 50mg/Kg in SAD cohort 4.
Group VII: SAD Cohort 3: ADEL Y-01 antibody at a dose of 20mg/KgActive Control1 Intervention
This arm represents the group receiving ADEL Y-01 antibody at a dose of 20mg/Kg in SAD cohort 3.
Group VIII: MAD Cohort 1: ADEL Y-01 antibody at a dose of 7.5mg/KgActive Control1 Intervention
This arm represents the group receiving ADEL Y-01 antibody at a dose of 7.5 mg/Kg in MAD cohort 1.
Group IX: SAD Cohort 5: Placebo at a dose of 100mg/KgPlacebo Group1 Intervention
This arm represents the group receiving placebo at a dose of 100mg/Kg in SAD cohort 5.
Group X: MAD Cohort 3: Placebo at a dose of 50mg/KgPlacebo Group1 Intervention
This arm represents the group receiving placebo at a dose of 50mg/Kg in MAD cohort 3.
Group XI: MAD Cohort 1: Placebo at a dose of 7.5mg/KgPlacebo Group1 Intervention
This arm represents the group receiving placebo at a dose of 7.5mg/Kg in MAD cohort 1.
Group XII: SAD Cohort 1: Placebo at a dose of 2.5mg/KgPlacebo Group1 Intervention
This arm represents the group receiving placebo at a dose of 2.5mg/Kg in SAD cohort 1.
Group XIII: SAD Cohort 2: Placebo at a dose of 7.5mg/KgPlacebo Group1 Intervention
This arm represents the group receiving placebo at a dose of 7.5mg/Kg in SAD cohort 2.
Group XIV: SAD Cohort 3: Placebo at a dose of 20mg/KgPlacebo Group1 Intervention
This arm represents the group receiving placebo at a dose of 20mg/Kg in SAD cohort 3.
Group XV: MAD Cohort 2: Placebo at a dose of 20mg/KgPlacebo Group1 Intervention
This arm represents the group receiving placebo at a dose of 20mg/Kg in MAD cohort 2.
Group XVI: SAD Cohort 4: Placebo at a dose of 50mg/KgPlacebo Group1 Intervention
This arm represents the group receiving placebo at a dose of 50mg/Kg in SAD cohort 4.

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Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Oscotec Inc.Industry Sponsor
7 Previous Clinical Trials
354 Total Patients Enrolled
Alzheimer's Disease Expert Lab (ADEL), Inc.Lead Sponsor
1 Previous Clinical Trials
7,000 Total Patients Enrolled
Seung-Yong YoonStudy ChairAlzheimer's Disease Expert Lab (ADEL), Inc.
~33 spots leftby Oct 2025
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