HOPO 14-1 for Chemical Toxicity Safety Study

No longer recruiting at 1 trial location

Overseen ByMedical Director

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: SRI International

Must not be taking: Laxatives, Antibiotics, Antacids

Disqualifiers: Pregnancy, Substance abuse, Organ transplant, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing the safety of a new treatment called HOPO 14-1, which may help with chemical toxicity. Researchers aim to determine if different doses, ranging from 100 mg to 7500 mg, are safe and well-tolerated by healthy participants. Individuals who are generally healthy and free of major medical issues may be suitable candidates. As a Phase 1 trial, participants have the opportunity to be among the first to receive this treatment and assist researchers in understanding its effects in people.

Do I have to stop taking my current medications for the trial?

The trial requires that you stop using laxatives, antibiotics, and antacids within 7 days of dosing. If you are taking any investigational drugs, you must stop them 60 days before dosing or 5 half-lives of the drug, whichever is longer.

Is there any evidence suggesting that HOPO 14-1 is likely to be safe for humans?

Research has shown that HOPO 14-1 is currently being tested for safety in humans. Initial studies focus on how well individuals tolerate various doses of this new treatment. As this study is in its early stages, scientists continue to gather data on its safety and how the body processes it.

If HOPO 14-1 had been approved for another use, more would be known about its safety. However, since this is its first test in humans, the primary goal is to ensure safety at different doses. Participants receive single doses ranging from 100 mg to 7500 mg, helping researchers determine safe amounts without harmful effects. As more data is collected, researchers will better understand how well people tolerate HOPO 14-1.¹ ² ³ ⁴ ⁵

Why do researchers think this study treatment might be promising?

Researchers are excited about HOPO 14-1 because it offers a novel approach to treating chemical toxicity. Unlike conventional treatments, which often focus on symptomatic relief or slowing the absorption of toxins, HOPO 14-1 is designed to directly bind and neutralize toxic chemicals in the body. This unique mechanism of action means it might work more efficiently and effectively than current options. Moreover, it is administered as a single oral dose, which could make it more convenient and faster-acting compared to treatments requiring multiple doses or intravenous administration.

What evidence suggests that HOPO 14-1 could be an effective treatment for chemical toxicity?

Research has shown that HOPO 14-1 effectively attaches to and removes radioactive materials from the body, performing up to 100 times better than DTPA, a current treatment for radioactive contamination. This suggests it could effectively treat chemical poisoning related to radioactive substances. Early studies indicate that HOPO 14-1 is safe, as it does not cause harmful effects in tested cells and animals. In this trial, participants will receive different dosages of HOPO 14-1 to evaluate its safety and effectiveness in humans, with the aim of achieving similar positive results.¹ ² ³ ⁵ ⁶

Who Is on the Research Team?

Principal Investigator

SRI International

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am in good health overall, according to my recent medical exams.

Agree to use contraception from time of screening until 14 days after dosing (Day 14) if female is of childbearing potential or male is with female partner of childbearing potential

Negative urine or blood screen for drugs of abuse (except if participant provides prescription justifying use prior to urine screen)

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Exclusion Criteria

I have not had a fever or serious infection in the last week.

Inability or unwillingness of a participant to give written informed consent or comply with study protocol

I have trouble swallowing pills.

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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single oral dose of HOPO 14-1 in varying doses across different cohorts

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety, tolerability, pharmacokinetics, and excretion after receiving the dose

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

HOPO 14-1

Trial Overview 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.

How Is the Trial Designed?

7Treatment groups

Experimental Treatment

Group I: Cohort 7: 7500 mgExperimental Treatment1 Intervention