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18F-OP-801 for Lou Gehrig's Disease

Phase 1 & 2

Recruiting

Research Sponsored by Ashvattha Therapeutics, Inc.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Female subjects of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the local laboratory's defined ranges.

Female subjects of childbearing potential must have negative result for pregnancy test at Screening and Check-in.

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Upsafety 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

Awards & highlights

No Placebo-Only Group

Study Summary

This trial will study the safety and how 18F-OP-801 (18F Hydroxyl Dendrimer) behaves in the body after being given intravenously to patients with ALS and healthy volunteers.

Eligible Conditions

Lou Gehrig's Disease

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 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

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

The number of participants with treatment emergent adverse events (Safety and Tolerability)

Secondary outcome measures

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

Other outcome measures

Biomarker levels in blood serum and plasma for each participant

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Healthy Volunteers participantsExperimental Treatment1 Intervention

Intravenous Administration of 18F-OP-801 (18F Hydroxyl Dendrimer)

Group II: Amyotrophic Lateral Sclerosis participantsExperimental Treatment1 Intervention

Intravenous Administration of 18F-OP-801 (18F Hydroxyl Dendrimer)

0 / 8Eligibility criteria met

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Ashvattha Therapeutics, Inc.Lead Sponsor

3 Previous Clinical Trials

74 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has recruitment for this clinical research commenced?

"The clinical trial's information hosted on clinicaltrials.gov suggest that this investigation is not currently recruiting, having been initially posted on July 15th 2022 and last edited on May 25th 2022. Despite this, there are 547 other medical trials actively seeking patients right now."

Answered by AI

Is 18F-OP-801 a secure compound to use for human consumption?

"Since 18F-OP-801 is currently undergoing Phase 1 trials, the safety rating for this drug was assessed as a 1 due to incomplete evidence of both efficacy and risk."

Answered by AI

Is eligibility for this clinical research open to senior citizens?

"Applicants to this medical trial must be between 18 and 80 years old in order to meet the set criteria. In addition, there are 44 trials for minors and 402 studies available that cater specifically towards individuals aged 65 or higher."

Answered by AI

Is it possible for me to enrol in this medical experiment?

"For this medical trial, 25 adult patients (aged 18-80) living with amyotrophic lateral sclerosis are being accepted. Participants must be able to comprehend and consent to the Informed Consent Form as well meet other criteria including: sterilization or postmenopausal status for women of non-childbearing potential, contraception use by both sexes, abstinence from sperm donation in males, negative pregnancy test results in reproductive females."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging Agent, 18F-OP-801 (18F Hydroxyl Dendrimer) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV)

2023. "A Study to Evaluate the Safety, Pharmacokinetics and Biodistribution of an Imaging Agent, 18F-OP-801 (18F Hydroxyl Dendrimer) in Patients With Amyotrophic Lateral Sclerosis (ALS) and Healthy Volunteers (HV)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05395624.

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