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

Part of paid clinical trials in San Francisco, California.

Sponsor
Ashvattha Therapeutics, Inc.
Study ID
NCT05395624
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Accepted

Interventions

  • 18F-OP-801 — DRUG
    18F Hydroxyl Dendrimer

Study Details

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.

Key Dates

Start date
Feb 2, 2023
Status verified
Apr 2025
Primary completion
Jan 1, 2026
Completion
May 1, 2026

Study Design

Enrollment
65 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: Healthy Volunteer participants
    Intravenous Administration of 18F-OP-801 (18F Hydroxyl Dendrimer)
  • Experimental: Amyotrophic Lateral Sclerosis participants
    Intravenous Administration of 18F-OP-801 (18F Hydroxyl Dendrimer)
  • Experimental: Alzheimer's Disease participants
    Intravenous Administration of 18F-OP-801 (18F Hydroxyl Dendrimer)
  • Experimental: Multiple Sclerosis participants
    Intravenous Administration of 18F-OP-801 (18F Hydroxyl Dendrimer)
  • Experimental: Parkinson's Disease participants
    Intravenous Administration of 18F-OP-801 (18F Hydroxyl Dendrimer)

Primary Outcome Measure

The number of participants with treatment emergent adverse events (Safety and Tolerability) [ Time Frame: Safety and tolerability of 18F-OP-801 as assessed by the frequency, and severity of treatment-emergent adverse events (TEAEs) from Day 1 to Day 15 or Day 18-29 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
UCSFSan FranciscoCalifornia94107
Hannah George
[email protected]
415-501-0671
Stanford UniversityStanfordCalifornia94305
Sierrah Hoover
[email protected]
650-723-3223
Mayo Clinic JacksonvilleJacksonvilleFlorida32224
Colette McHugh-Strong, JD
[email protected]
904-953-4965

Find similar trials in San Francisco, CA

By research site
UCSF· San Francisco, CAStanford University· Stanford, CAMayo Clinic Jacksonville· Jacksonville, FL

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