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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: Recruiting Phase 1 study of Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis, MS, sponsored by Ashvattha Therapeutics.
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 299-participant average among 18 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (78% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Safety of single dose of 18F-OP-801 as measured by treatment-related adverse events as assessed by CTCAE v5.0
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 |
What NCT05395624 shows while recruiting
NCT05395624 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 299-participant average among 18 other Amyotrophic Lateral Sclerosis (ALS) trials with a reported enrollment target (78% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Amyotrophic Lateral Sclerosis (ALS)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05395624's enrollment target sits among peer trials
65 12th of 18 higher than 7 of 18 other Amyotrophic Lateral Sclerosis (ALS) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Amyotrophic Lateral Sclerosis (ALS) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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