HOPO 14-1 for Chemical Toxicity Safety Study

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 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.

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.

How does the drug HOPO 14-1 differ from other treatments for chemical toxicity?

The research provided does not contain specific information about HOPO 14-1 or its unique characteristics compared to other treatments for chemical toxicity.¹ ² ³ ⁴ ⁵

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

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)

I understand the study's requirements and agree to follow them.

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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