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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
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
7Treatment groups
Experimental Treatment
Group I: Cohort 7: 7500 mgExperimental Treatment1 Intervention
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
Group II: Cohort 6: 5000 mgExperimental Treatment1 Intervention
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
Group III: Cohort 5: 2500 mgExperimental Treatment1 Intervention
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
Group IV: Cohort 4: 1200 mgExperimental Treatment1 Intervention
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
Group V: Cohort 3: 500 mgExperimental Treatment1 Intervention
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
Group VI: Cohort 2: 200 mgExperimental Treatment1 Intervention
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
Group VII: Cohort 1: 100 mgExperimental Treatment1 Intervention
Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
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.
Environmental impact assessment of COVID-19 therapeutic solutions. A prospective analysis.
Environmental impact assessment of COVID-19 therapeutic solutions. A prospective analysis.
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Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
SRI InternationalLead Sponsor
17 Previous Clinical Trials
9,668 Total Patients Enrolled
Principal InvestigatorPrincipal InvestigatorSRI International
39 Previous Clinical Trials
5,060 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a fever or serious infection in the last week.I have trouble swallowing pills.I have received an organ or bone marrow transplant.I have not had chelation therapy in the last year.I haven't taken any experimental drugs recently.I have had health issues found through exams or tests.I understand the study's requirements and agree to follow them.I am in good health overall, according to my recent medical exams.I haven't used laxatives, antibiotics, or antacids in the last week.My weight is between 50kg and 110kg, or if over, my BMI is ≤ 40.I've felt very lightheaded or faint, had balance problems, or extreme tiredness within 2 days after taking medication.I have not had a blood transfusion in the last 3 months.My weight is between 50kg and 110kg, or if over, my BMI is ≤ 40.I am in good health overall, according to my recent medical exams.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 1: 100 mg
- Group 2: Cohort 2: 200 mg
- Group 3: Cohort 7: 7500 mg
- Group 4: Cohort 3: 500 mg
- Group 5: Cohort 5: 2500 mg
- Group 6: Cohort 4: 1200 mg
- Group 7: Cohort 6: 5000 mg
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Chemical Toxicity Patient Testimony for trial: Trial Name: NCT05628961 — Phase 1