18F-OP-801 for Amyotrophic Lateral Sclerosis

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Stanford University, Stanford, CA
Amyotrophic Lateral Sclerosis+3 More
18F-OP-801 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

A Phase 1 Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging agent, 18F-OP-801 (18F Hydroxyl Dendrimer), After Intravenous Administration to Patients with Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV)

Eligible Conditions

  • Amyotrophic Lateral Sclerosis

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Amyotrophic Lateral Sclerosis

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 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

Day 18
The number of participants with treatment emergent adverse events (Safety and Tolerability)
Day 18
Measurement of biodistribution of 18F-OP-801 for each participant
Measurement of clearance of 18F-OP-801 for each participant
Uptake of 18F-OP-801 in ALS participants

Trial Safety

Safety Progress

1 of 3

Other trials for Amyotrophic Lateral Sclerosis

Trial Design

2 Treatment Groups

Healthy Volunteers participants
1 of 2
Amyotrophic Lateral Sclerosis participants
1 of 2
Experimental Treatment

25 Total Participants · 2 Treatment Groups

Primary Treatment: 18F-OP-801 · No Placebo Group · Phase 1

Healthy Volunteers participants
Drug
Experimental Group · 1 Intervention: 18F-OP-801 · Intervention Types: Drug
Amyotrophic Lateral Sclerosis participants
Drug
Experimental Group · 1 Intervention: 18F-OP-801 · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 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
Closest Location: Stanford University · Stanford, CA
Photo of Stanford University 1Photo of Stanford University 2Photo of Stanford University 3
1992First Recorded Clinical Trial
4 TrialsResearching Amyotrophic Lateral Sclerosis
774 CompletedClinical Trials

Who is running the clinical trial?

Ashvattha Therapeutics, Inc.Lead Sponsor
3 Previous Clinical Trials
330 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have the ability to understand and sign the ICF and local medical privacy authorization forms, which must be obtained prior to the conduct of any study related procedures.
Subjects must be female of childbearing potential and must use a medically accepted contraceptive regimen (including hormonal contraceptives) during the study and for 90 days (males) or 6 months (females) after Day 1.
The test subject must be at least 18 years of age.
Subjects must agree to abstain from sperm donation through 90 days after the Day 1 Visit.
You are female of childbearing potential.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.