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 14 days

Awards & highlights

Study Summary

This trial studies the safety and effectiveness of a new drug, HOPO 14-1, given as a single, oral dose up to 7500 mg to healthy participants.

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.Check my eligibility

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.See study design

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 14 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 14 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 14 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of Participants with One or More Adverse Events

Number of Participants with One or More Adverse Events by Maximum Severity

Number of Participants with One or More Drug-Related Adverse Events

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Secondary outcome measures

Apparent Volume of Distribution after Oral Administration (V/F)

Area Under the Plasma Concentration Time Curve up to the Last Blood Collection Time with a Measurable Concentration (AUClast)

Cumulative Amount Excreted in Feces

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