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

NCT05395624 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-05-02

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

18F-OP-801

18F Hydroxyl Dendrimer

Sponsors & Collaborators

  • Ashvattha Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Farshad Moradi, MD · Stanford University

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-02-02
Primary Completion
2026-01-01
Completion
2026-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT05395624 on ClinicalTrials.gov