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NCT05395624 · ClinicalTrials.gov registry record · Phase 1
Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers
A Phase 1 study of Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis, MS, sponsored by Ashvattha Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 65
- Enrollment target
- 3
- Study locations
NCT05395624 is a Phase 1 study of Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis, MS that is actively recruiting participants, run by Ashvattha Therapeutics. The registered enrollment target is 65 participants, below the 257-participant average among 17 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (75% lower). The trial reports 3 study locations across 2 states.
The verdict
NCT05395624, a Phase 1 study of Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis, MS, is actively recruiting participants, sponsored by Ashvattha Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 65 participants
- Enrollment target
- 3
- Study locations
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 Studied
Interventions
- DRUG 18F-OP-801
Study Locations (3)
California
- UCSF - San Francisco
- Stanford University - Stanford
Florida
- Mayo Clinic Jacksonville - Jacksonville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2023-02-02 |
| Est. Completion | 2026-05-01 |
| Phase | Phase 1 |
Interested in This Trial?
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, categorized as Phase 1. The registered enrollment target is 65 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 257-participant average among 17 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (75% lower). The listed sponsor is Ashvattha Therapeutics, which has 3 total studies on file at ClinicalTrials.gov.
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.
NCT05395624 reports 3 study locations spanning 2 distinct geographic areas - top geographies include California, Florida.
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).
What interventions are being tested in trial NCT05395624?
The interventions under investigation include: 18F-OP-801 (DRUG).
Who is sponsoring clinical trial NCT05395624?
This trial is sponsored by Ashvattha Therapeutics, which has 3 total clinical trials registered on ClinicalTrials.gov.
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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.