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NOT YET RECRUITING
NCT07568041
PHASE1

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

Sponsor: Cenna Biosciences Inc.

View on ClinicalTrials.gov

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.

Official title: A Phase Ia (SAD/MAD), Randomized, Double-Blind, Placebo-Controlled Trial and Phase Ib Open-Label Trial to Evaluate Safety, Tolerability, PK, and Exploratory Immunogenicity of Single and Multiple Doses of 8M2D in Healthy Participants and Early AD Participants.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

54

Start Date

2026-09-15

Completion Date

2027-12

Last Updated

2026-05-05

Healthy Volunteers

Yes

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.