RecruitingPhase 1Phase 2NCT05395624

Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers

A Phase 1/2 Study to Evaluate Safety, PK and Biodistribution of an Imaging Agent, 18F-OP-801, After Intravenous Administration to Patients With ALS, Alzheimer's Disease, Multiple Sclerosis, Parkinson's Disease and Healthy Volunteers

Sponsor

Ashvattha Therapeutics, Inc.

Enrollment

65 participants

Start Date

Feb 2, 2023

Study Type

INTERVENTIONAL

Conditions

Amyotrophic Lateral Sclerosis(ALS)Alzheimer Disease (AD)Parkinson Disease (PD)Multiple Sclerosis (MS)

Summary

This is a Phase 1/2 study to evaluate the safety and tolerability of 18F-OP-801 in subjects with ALS, AD, MS, PD and age-matched HVs. 18F-OP-801 is intended as a biomarker for PET imaging of activated microglia and macrophages in regions of neuroinflammation.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new PET scan imaging agent called 18F-OP-801 to see how it distributes in the body and whether it is safe. The scan may help detect brain inflammation in people with neurological diseases. **You may be eligible if...** - You are 18 years old or older - You are a healthy volunteer, OR you have been diagnosed with ALS, Alzheimer's disease, multiple sclerosis, or Parkinson's disease - You are able to understand and sign the consent form - Women of childbearing potential must use effective contraception **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have significant kidney or liver problems - You have a condition that makes MRI or PET scanning unsafe (e.g., certain metal implants) - You have used certain other study drugs recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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