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.
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.
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.
Sequential
8M2D
Drug8M2D administered by subcutaneous injection. Evaluated across single ascending doses (Part I) and multiple ascending doses (Part II) in healthy participants, and as multiple doses in participants with early Alzheimer's disease (Part III).
Placebo
DrugMatching placebo administered by subcutaneous injection in healthy participants across the single ascending dose (Part I) and multiple ascending dose (Part II) parts of the study.
Number of participants reporting treatment-emergent adverse events
A treatment-emergent adverse event is defined as any adverse event that has an onset on or after the first dose of the trial medication, or any pre-existing condition that has worsened on or after the first dose of the trial intervention.
Number of participants reporting treatment-emergent adverse events that require discontinuation of therapy due to intolerable side effects
Evaluation of the number of participants withdrawn from study medication due to treatment-emergent adverse events.
Number of participants reporting injection site reactions
Evaluation of skin reactions at the injection site, including pain, itching, and swelling or redness around the injection site.
Number of participants demonstrating abnormal laboratory findings
Evaluation of laboratory results outside the documented normal range as defined by the clinical laboratory.
Assessment of the presence of anti-8M2D antibody in participants of all cohorts.
Evaluation of anti-8M2D antibody presence in blood samples collected from all participants.
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This trial is not recruiting at the moment. You can still explore other options:
