HOPO 14-1 for Chemical Toxicity Safety Study

Overseen By Medical 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

42 Participants Needed

Trial Summary

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}

Research Team

Principal Investigator

Principal Investigator

SRI International

Eligibility Criteria

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.

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.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Cohort 7: 7500 mg Experimental Treatment 1 Intervention

Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.

Group II: Cohort 6: 5000 mg Experimental Treatment 1 Intervention

Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.

Group III: Cohort 5: 2500 mg Experimental Treatment 1 Intervention

Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.

Group IV: Cohort 4: 1200 mg Experimental Treatment 1 Intervention

Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.

Group V: Cohort 3: 500 mg Experimental Treatment 1 Intervention

Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.

Group VI: Cohort 2: 200 mg Experimental Treatment 1 Intervention

Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.

Group VII: Cohort 1: 100 mg Experimental Treatment 1 Intervention

Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.

Who Is Running the Clinical Trial?

SRI International

Lead Sponsor

Trials

18

Recruited

9,700+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

The added value of the 90-day repeated dose oral toxicity test for industrial chemicals with a low (sub)acute toxicity profile in a high quality dataset. [2014]

2. England pubmed.ncbi.nlm.nih.gov

The future of toxicity testing: a focus on in vitro methods using a quantitative high-throughput screening platform. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A research to develop a predicting system of mammalian subacute toxicity. II. Single dose detailed toxicity studies. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Acute oral toxicity. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The IPCS Collaborative Study on Neurobehavioral Screening Methods: II. Protocol design and testing procedures. [2007]