A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Cl… (NCT06247345) | Clinical Trial Compass
TerminatedPhase 1
A Phase Ia/Ib, First-in-human (FIH) Study for Safety, Tolerability, Pharmacokinetics (PK), and Clinical Activity Evaluation of ADEL-Y01
Stopped: Study discontinued due to sponsor transition and strategic decision not to continue the protocol.
United States42 participantsStarted 2024-02-06
Plain-language 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 \[MAD\]).
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Provision of signed and dated, written informed consent prior to any study specific procedures.
. Healthy male and/or female (of nonchildbearing potential) participants aged 18 to 65 years, inclusive.
. A body mass index (BMI) between 18 to 30 kg/m2, inclusive.
. Females must have a negative pregnancy test at the Screening Visit and on admission to the study center, must not be lactating and must be of nonchildbearing potential, confirmed at the Screening Visit by fulfilling 1 of the following criteria:
. Male participants should be willing to use double barrier contraception ie., condoms and spermicide, from the day of dosing until at least 3 months after dosing with the investigational product.
. Male participant must not donate sperm from the day of dosing until at least 3 months after dosing with the investigational product.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Part 1: Evaluation of the safety and tolerability of ADEL-Y01 via single IV injection
Timeframe: D-28 ~ Week 12
2
Part 2: Assessment of safety and tolerability with multiple IV Administrations of ADEL-Y01 in participants with MCI due to AD or Mild AD
Timeframe: D-28 ~ Week 22
Trial details
NCT IDNCT06247345
SponsorAlzheimer's Disease Expert Lab (ADEL), Inc.
. Medically healthy with clinically insignificant screening results (eg, laboratory profiles, medical history, electrocardiograms \[ECGs\], and physical examination) as judged by the Principal Investigator.
. Has to agree to abstain from alcohol intake 48 hours before administration of the study intervention and through the follow-up visit.
Exclusion criteria
. History of any clinically important disease or disorder (major medical illnesses like cancer within 5 years, unstable angina or recent myocardial infarction, and renal failure) which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
. History or presence of gastrointestinal, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.
. Any current active infections, including localized infections, or any recent history (within 1 week prior to study intervention administration) of active infections (including severe acute respiratory syndrome coronavirus 2 \[SARS-CoV-2\], cough or fever, or a history of recurrent or chronic infections).
. Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product or planned surgical procedure during the study period.
. Any positive result at the Screening Visit for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus.
. Blood donation within 1 month of screening or any blood donation/blood loss greater than 500 mL during the 3 months prior to screening.
. Abnormal vital signs, after 10 minute supine rest at the Screening Visit and on Day -1, defined as any of the following:
. Any clinically important abnormalities in rhythm, conduction or morphology of the resting ECG, and any clinically important abnormalities in the 12-lead ECG as considered by the Investigator that may interfere with the interpretation of QTc interval changes.