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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
Body weight ≥ 50 kilogram (kg) and ≤ 110 kg. If body weight is over 110 kg, then body mass index (BMI) will be considered and must be ≤ 40 kg/m^2
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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My weight is between 50kg and 110kg, or if over, my BMI is ≤ 40.

Timeline

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
+1 more
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
+6 more

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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

SRI InternationalLead Sponsor
16 Previous Clinical Trials
9,648 Total Patients Enrolled
Principal InvestigatorPrincipal InvestigatorSRI International
33 Previous Clinical Trials
4,027 Total Patients Enrolled

Media Library

HOPO 14-1 (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05628961 — Phase 1
Chemical Toxicity Research Study Groups: Cohort 1: 100 mg, Cohort 2: 200 mg, Cohort 3: 500 mg, Cohort 4: 1200 mg, Cohort 5: 2500 mg, Cohort 6: 5000 mg, Cohort 7: 7500 mg
Chemical Toxicity Clinical Trial 2023: HOPO 14-1 Highlights & Side Effects. Trial Name: NCT05628961 — Phase 1
HOPO 14-1 (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05628961 — Phase 1
Chemical Toxicity Patient Testimony for trial: Trial Name: NCT05628961 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this clinical study enrolling individuals aged 55 and over?

"According to the prerequisites outlined for this trial, individuals aged 18 and older but younger than 65 are eligible to participate."

Answered by AI

Is there any danger associated with administering Cohort 1: 100 mg to patients?

"Due to the lack of data concerning Cohort 1: 100 mg's safety and efficacy, our team ranked its risk level at a low score of 1."

Answered by AI

Is recruitment presently taking place for this trial?

"Affirmative. Records on clinicaltrials.gov verify that this scientific trial, which was first uploaded on March 15th 2023, is actively recruiting patients. Around 42 individuals must be enlisted from a single medical facility."

Answered by AI

How many individuals have been recruited to participate in this experiment?

"Affirmative. According to clinicaltrials.gov, this study is still open for recruitment and was first published on March 15th 2023 with the latest update occurring May 22nd of that same year. At present, 42 patients are needed from a single location."

Answered by AI

Who has the potential to be accepted into this research protocol?

"This clinical trial is looking for 42 adults between 18 and 65 years of age with chemical toxicity. Applicants must demonstrate their understanding of the study protocol, provide written consent, use contraception if applicable, be in good health according to medical history and tests results, pass a drug test unless prescribed medication can explain any positives on the urine or blood screen, weigh at least 50 kg but less than 110 kg (if over that weight then BMI should not exceed 40)."

Answered by AI

Who else is applying?

What state do they live in?
Michigan
What site did they apply to?
SRI Biosciences Clinical Trials Unit
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

What questions have other patients asked about this trial?

When does the trial start and end? Is the trial a inpatient or outpatient study?
PatientReceived no prior treatments

Why did patients apply to this trial?

I have a friend who suggested I try being a healthy volunteer.
PatientReceived no prior treatments
~0 spots leftby Apr 2024