Phase 1 Study to Evaluate the Safety and Tolerability of 8M2D in Healthy People and Alzheimer's P… (NCT07568041) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Phase 1 Study to Evaluate the Safety and Tolerability of 8M2D in Healthy People and Alzheimer's Patients
54 participantsStarted 2026-09-15
Plain-language summary
This study is testing a new investigational drug called 8M2D to learn whether it is safe and well-tolerated in humans. 8M2D has not previously been given to people.
Hypothesis: Researchers believe that 8M2D can be administered safely to healthy adults and to people with early Alzheimer's disease, and that it may reduce levels of amyloid beta. Amyloid beta is a protein that builds up in the brains of people with Alzheimer's disease and is thought to contribute to its progression.
The study will be conducted in three parts. In the first two parts, healthy volunteers will receive either a single dose or multiple doses of 8M2D so researchers can understand how the drug moves through the body and whether it causes any side effects. In the third part, a small group of people with early Alzheimer's disease will receive multiple doses so researchers can also begin to assess whether the drug has any effect on amyloid beta levels.
Doses will be increased gradually and carefully. An independent safety board will review safety information before any dose increase is allowed. The information gathered in this study will be used to identify the appropriate dose of 8M2D and to help design future studies in people with Alzheimer's disease.
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion criteria
✓. Voluntarily consents to participate in this trial and provides written informed consent before the start of any trial assessments.
✓. Healthy male and female adults, 18 and 55 years of age (inclusive).
✓. Participants with a body mass index (BMI) ≥ 18 and ≤ 32 kg/m2 (inclusive) and weigh a minimum of 50 kg.
✓. Participants with a normal 12-lead ECG at Screening.
✓. Participant has normal renal function.
✓. Females participants must meet one of the following criteria:
✓. Males with a sexual partner who is a female of childbearing potential must be surgically sterile, or agree to use condoms with spermicide or abstain from sexual intercourse, starting from Screening until 90 days after the last dose of the trial medication.
✓. Participant is willing and able to complete all trial assessments in compliance with the protocol and is able to remain in the inpatient treatment unit for the entire duration of the confinement period and return for outpatient visits.
Exclusion criteria
What they're measuring
1
Number of participants reporting treatment-emergent adverse events
Timeframe: Baseline to Day 44
2
Number of participants reporting treatment-emergent adverse events that require discontinuation of therapy due to intolerable side effects
Timeframe: Baseline to Day 14
3
Number of participants reporting injection site reactions
Timeframe: Baseline to Day 22
4
Number of participants demonstrating abnormal laboratory findings
Timeframe: Baseline to Day 14
5
Number of participants demonstrating abnormal vital signs
Timeframe: Baseline to Day 22
6
Number of participants demonstrating abnormal vital electrocardiogram (ECG) parameters
Timeframe: Baseline to Day 15
7
Number of participants demonstrating adverse changes in physical and/or neurologic examinations
Timeframe: Baseline to Day 22
8
Number of participants reporting changes in Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline
✕. History or presence of clinically significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, oncologic, or psychiatric disease or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the participant or the validity of the trial results.
✕. Participant has abnormal laboratory values detected at Screening or on clinic admission (Day -1) that suggest a clinically significant underlying disease.
✕. Participant who shows evidence of suicidal ideation as assessed by the C-SSRS at screening and at Day -1 or history of suicide attempt (lifetime).
✕. Participant with positive serology for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) at Screening.
✕. Participant smokes cigarettes or uses other nicotine-containing products in the past 3 months prior to Screening.
✕. Participant with regular alcohol consumption within 6 months prior to the trial defined as an average weekly intake of \> 20 units for males or \> 16 units for females (8g ethanol = 1 unit).
✕. Participant tests positive in the urine test for alcohol, cotinine, and/or screen for drugs of abuse at the time of screening or Day -1.
✕. Participant with a history of drug abuse according to Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM V criteria or later) within the 2 years prior to study entry.
Timeframe: Baseline to Day 22
9
Maximum observed concentration (Cmax) of 8M2D
Timeframe: Baseline to Day 14
10
Time to maximum observed concentration (tmax) of 8M2D
Timeframe: Baseline to Day 14
11
Area under the concentration-time curve from time 0 to the last quantifiable concentration (AUC-last) of 8M2D
Timeframe: Baseline to Day 14
12
Terminal phase half-life (t1/2)
Timeframe: Baseline to Day 14
13
Area under the concentration-time curve from time 0 to infinity (AUC-inf)
Timeframe: Baseline to Day 14
14
Assessment of changes from baseline after 14 days of dosing in plasma and CSF biomarkers of AD [such as Aβ42, Aβ40, p-tau217, and np-tau217