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RECRUITING Phase 1

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

NCT05395624 · View on ClinicalTrials.gov ↗

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.

Interventions

  • DRUG 18F-OP-801

Study Locations (3)

California

  • UCSF — San Francisco
  • Stanford University — Stanford

Florida

  • Mayo Clinic Jacksonville — Jacksonville

Trial Details

FieldValue
Enrollment Target 65 participants
Start Date 2023-02-02
Est. Completion 2026-05-01
Phase Phase 1

Sponsor

Ashvattha Therapeutics

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05395624

The ClinicalTrials.gov registry entry for NCT05395624 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Ashvattha Therapeutics, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 4 conditions, with Amyotrophic Lateral Sclerosis (ALS) appearing as the primary indexed condition, and to 1 intervention — of which 18F-OP-801 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT05395624 reports 3 study locations spanning 2 distinct geographic areas — top geographies include California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT05395624 about?

NCT05395624 is a clinical study titled "Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers". 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.

What is the current status of trial NCT05395624?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 65 participants. The study started on 2023-02-02. Estimated completion is 2026-05-01.

What conditions does trial NCT05395624 study?

This clinical trial studies the following conditions: Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS), Alzheimer Disease (AD), Parkinson Disease (PD). These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05395624?

The interventions under investigation include: 18F-OP-801 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05395624?

This trial is sponsored by Ashvattha Therapeutics, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT05395624 being conducted?

This trial has 3 study locations across California, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial