What is the mechanism of action of this treatment?

The most common treatments for chemical toxicity often involve chelating agents, which bind to toxic metals in the body and facilitate their excretion. HOPO 14-1, for example, is being studied for its safety and tolerability as a chelating agent. These treatments are crucial for chemical toxicity patients because they help to reduce the body's toxic burden, prevent further damage to organs, and improve overall health outcomes by removing harmful substances more efficiently.

What side effects are associated with this type of intervention?

Common treatments for chemical toxicity, such as chelation therapy, often involve agents like EDTA, DMSA, and DMPS. These treatments can cause side effects including gastrointestinal distress (nausea, vomiting, diarrhea), allergic reactions, and, in some cases, nephrotoxicity (kidney damage). For treatments similar to HOPO 14-1, which is being studied for safety and tolerability, side effects may include mild gastrointestinal symptoms and potential alterations in kidney function, though specific data on HOPO 14-1 is still being evaluated.

What prior FDA approvals exist?

The FDA has approved several chelating agents for the treatment of chemical toxicity. For example, dimercaprol (BAL) is used for arsenic, gold, and mercury poisoning, while edetate calcium disodium (EDTA) is approved for lead poisoning. Another chelating agent, succimer (DMSA), is also used for lead toxicity. These agents work by binding to heavy metals in the body, allowing them to be excreted more easily. The study of HOPO 14-1 appears to be in line with these types of treatments, focusing on safety and tolerability in managing chemical toxicity.

What other types of research exist?

Promising novel alternatives to HOPO 14-1 for chemical toxicity patients include the use of chelating agents such as dimercaptosuccinic acid (DMSA) and dimercaprol (BAL), which have shown efficacy in binding and removing heavy metals from the body. Additionally, advancements in gene therapy and the development of targeted molecular therapies are being explored for their potential to mitigate chemical toxicity. These alternatives are being evaluated for their safety and tolerability in ongoing clinical trials and may offer new treatment options by 2024.

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HOPO 14-1 for Chemical Toxicity Safety Study

Phase 1

Recruiting

Led By Principal Investigator

Research Sponsored by SRI International

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a pill called HOPO 14-1 in healthy people to see if it is safe and well-tolerated. The pill helps remove harmful radioactive substances from the body.

Who is the study for?

Healthy individuals who understand the study, can consent to it, and follow its rules. They must use contraception if applicable, have a body weight of 50-110 kg (or BMI ≤ 40 if over 110 kg), and test negative for drugs unless prescribed. People with certain lab abnormalities, heart issues, recent illness or transfusions, difficulty swallowing pills, or positive tests for hepatitis B/C, HIV or COVID-19 cannot join.

What is being tested?

The trial is testing different single doses of an oral capsule called HOPO 14-1 on healthy people to see how safe it is and how the body processes it. The highest dose they'll try is up to 7500 mg. Researchers will watch how participants feel after taking it and measure levels in their blood over time.

What are the potential side effects?

Since this is a first-in-human study assessing safety and tolerability of HOPO 14-1 at various doses in healthy volunteers, specific side effects are not yet known but will be closely monitored throughout the trial.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

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