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Phase 1 Study to Evaluate the Safety and Tolerability of 8M2D in Healthy People and Alzheimer's Patients

NCT07568041 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • Alzheimer's Disease (AD)

Interventions

DRUG

8M2D

8M2D 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).

DRUG

Placebo

Matching 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.

Sponsors & Collaborators

  • Cenna Biosciences Inc.

    lead INDUSTRY

Principal Investigators

  • Nazneen Dewji, PhD · Cenna Biosciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-09-15
Primary Completion
2027-09-30
Completion
2027-12-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07568041 on ClinicalTrials.gov