Toxicity;ChemicalPhase 1NCT05628961
Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics
A Phase 1 study testing HOPO 14-1 in people with Toxicity;Chemical, run by SRI International at 1 site in United States.
Trial summary
The study objectives are to define the safety and tolerability profile of oral, single ascending dose (SAD) levels of HOPO 14-1 capsules in cohorts of healthy participants and to assess the pharmacokinetic (PK) and excretion profile of HOPO 14-1. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Toxicity;Chemical
- What is being tested?
- HOPO 14-1
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2023to 4 Aug 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ability of participant to understand the requirements of the study, provide written informed consent, and agree to abide by the study requirements
- 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.
- In good general health based on medical history, physical examination (PE), and screening evaluations.
- Negative urine screen for drugs of abuse (except if participant provides prescription justifying use prior to urine screen).
- 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.
Who cannot join
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Any hematology, chemistry, coagulation, or urinalysis value on screening labs defined in the United States Food and Drug Administration (FDA) Guidance for Industry Toxicity Grading Scale as Grade 1 or higher.
- Any clinically significant electrocardiogram (ECG) abnormality
- Pregnant or breastfeeding
- Active substance abuse or history of any medical or psychiatric condition that would jeopardize the participant's safety or the participant's ability to comply with the protocol.
- Received an organ transplant (solid or bone marrow).
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- Received a blood transfusion within 3 months of dosing.
- Difficulty swallowing tablets or capsules.
- Febrile illness or significant infection within 7 days of dosing.
- Symptoms of hypotension (lightheadedness, syncope, balance disturbances, or extreme fatigue) within 48 hours of dosing.
- Hepatitis B virus surface antigen (HBsAg) positive or serologic (antibody positive) evidence of infection with hepatitis C virus (HCV) or human immunodeficiency virus (HIV).
- Tested positive for SARS-CoV-2 (COVID-19) within 21 days of dosing.
- Chelation therapy (e.g., ethylenediaminetetraacetic acid [EDTA], diethylenetriamine pentaacetate [DTPA]) in the past year.
- Use of laxatives, antibiotics, and/or antacids within 7 days of dosing.
- Use of investigational drugs within 60 days of dosing or 5 half-lives, whichever is longer.
- Received a vaccination within 30 days of dosing.
- Potential allergic reaction to product (oleic acid or HOPO 14-1 product).
- Past or current medical problems or findings from physical examination (PE) or laboratory testing
Trial locations and contacts
1 site in 1 country.
United States1 site
SRI International Clinical Trials Unit
Plymouth, Michigan, 48170
About this study
Official title: An Open-Label, First-In-Human Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics, and Excretion in Healthy Participants
The study objectives are to define the safety and tolerability profile of oral, single ascending dose (SAD) levels of HOPO 14-1 capsules in cohorts of healthy participants and to assess the pharmacokinetic (PK) and excretion profile of HOPO 14-1. The study hypothesis is that a single dose of HOPO 14-1 will be safe and tolerable up to 7500 mg.
Read the detailed description
The currently available therapy for radionuclide internal contamination is suboptimal. Pharmacological and toxicological data support the clinical development of HOPO 14-1 for decorporation of radionuclides.
- Conditions
- Toxicity;Chemical
- Being tested
- HOPO 14-1
- Keywords
- Internal Radionuclide Contamination
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HOPO 14-1Drug
HOPO 14-1 contains the active pharmaceutical ingredient (API) 3, 4, 3-LI(1, 2-HOPO) formulated with a permeability enhancer, sodium oleate, in capsule form.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: 100 mg | Experimental | Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. Receives: Drug: HOPO 14-1 |
| Cohort 2: 200 mg | Experimental | Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. Receives: Drug: HOPO 14-1 |
| Cohort 3: 500 mg | Experimental | Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. Receives: Drug: HOPO 14-1 |
| Cohort 4: 1200 mg | Experimental | Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. Receives: Drug: HOPO 14-1 |
| Cohort 5: 2500 mg | Experimental | Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. Receives: Drug: HOPO 14-1 |
| Cohort 6: 5000 mg | Experimental | Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. Receives: Drug: HOPO 14-1 |
| Cohort 7: 7500 mg | Experimental | Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. Receives: Drug: HOPO 14-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Adverse Events
Measured: Up to 14 days
Number of Participants with One or More Drug-Related Adverse Events
Measured: Up to 14 days
Number of Participants with One or More Adverse Events by Maximum Severity
Measured: Up to 14 days
Number of Participants with One or More Serious Adverse Events
Measured: Up to 14 days
Secondary outcomes (9)
Observed Maximum Plasma Concentration (Cmax)
Measured: Up to Day 7
Observed Time to Reach Cmax (Tmax)
Measured: Up to Day 7
Area Under the Plasma Concentration Time Curve up to the Last Blood Collection Time with a Measurable Concentration (AUClast)
Measured: Up to Day 7
Extrapolated to Infinity (AUC0-inf)
Measured: Up to Day 7
Terminal Half-Life (t 1/2)
Measured: Up to Day 7
Apparent Volume of Distribution after Oral Administration (V/F)
Measured: Up to Day 7
Oral Systemic Clearance Rate (CL/F)
Measured: Up to Day 7
Cumulative Amount Excreted in Urine
Measured: Up to Day 7
Cumulative Amount Excreted in Feces
Measured: Up to Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2022
- Study start15 Mar 2023
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Toxicity;ChemicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- SRI International
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05628961
- Sponsor's protocol ID
- SRI-HOPO-01
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2022
- Last updated
- 14 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, First-In-Human Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics, and Excretion in Healthy Participants
- ClinicalTrials.gov ID
- NCT05628961
- Acronym / sponsor ID
- SRI-HOPO-01
- Conditions
- Toxicity;Chemical
- Keywords
- Internal Radionuclide Contamination
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- SRI InternationalIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2023 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 29 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study objectives are to define the safety and tolerability profile of oral, single ascending dose (SAD) levels of HOPO 14-1 capsules in cohorts of healthy participants and to assess the pharmacokinetic (PK) and excretion profile of HOPO 14-1. The study hypothesis is that a single dose of HOPO 14-1 will be safe and tolerable up to 7500 mg.
Detailed description
The currently available therapy for radionuclide internal contamination is suboptimal. Pharmacological and toxicological data support the clinical development of HOPO 14-1 for decorporation of radionuclides.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: 100 mg | Experimental | Drug: HOPO 14-1Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. |
| Cohort 2: 200 mg | Experimental | Drug: HOPO 14-1Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. |
| Cohort 3: 500 mg | Experimental | Drug: HOPO 14-1Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. |
| Cohort 4: 1200 mg | Experimental | Drug: HOPO 14-1Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. |
| Cohort 5: 2500 mg | Experimental | Drug: HOPO 14-1Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. |
| Cohort 6: 5000 mg | Experimental | Drug: HOPO 14-1Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. |
| Cohort 7: 7500 mg | Experimental | Drug: HOPO 14-1Participants receive an oral single dose of HOPO 14-1 in the fasted condition on Day 1. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Ability of participant to understand the requirements of the study, provide written informed consent, and agree to abide by the study requirements
- 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.
- In good general health based on medical history, physical examination (PE), and screening evaluations.
- Negative urine screen for drugs of abuse (except if participant provides prescription justifying use prior to urine screen).
- 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.
Key exclusion criteria (18 listed)
- Inability or unwillingness of a participant to give written informed consent or comply with study protocol.
- Any hematology, chemistry, coagulation, or urinalysis value on screening labs defined in the United States Food and Drug Administration (FDA) Guidance for Industry Toxicity Grading Scale as Grade 1 or higher.
- Any clinically significant electrocardiogram (ECG) abnormality
- Pregnant or breastfeeding
- Active substance abuse or history of any medical or psychiatric condition that would jeopardize the participant's safety or the participant's ability to comply with the protocol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HOPO 14-1HOPO 14-1 contains the active pharmaceutical ingredient (API) 3, 4, 3-LI(1, 2-HOPO) formulated with a permeability enhancer, sodium oleate, in capsule form. | Drug | 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 |
Primary outcome
Number of Participants with One or More Adverse Events
Time frame: Up to 14 days
Number of Participants with One or More Drug-Related Adverse Events
Time frame: Up to 14 days
Number of Participants with One or More Adverse Events by Maximum Severity
Time frame: Up to 14 days
Number of Participants with One or More Serious Adverse Events
Time frame: Up to 14 days
9 secondary outcomes
Observed Maximum Plasma Concentration (Cmax)
Time frame: Up to Day 7
Observed Time to Reach Cmax (Tmax)
Time frame: Up to Day 7
Area Under the Plasma Concentration Time Curve up to the Last Blood Collection Time with a Measurable Concentration (AUClast)
Time frame: Up to Day 7
Extrapolated to Infinity (AUC0-inf)
Time frame: Up to Day 7
Terminal Half-Life (t 1/2)
Time frame: Up to Day 7
Apparent Volume of Distribution after Oral Administration (V/F)
Time frame: Up to Day 7
Oral Systemic Clearance Rate (CL/F)
Time frame: Up to Day 7
Cumulative Amount Excreted in Urine
Time frame: Up to Day 7
Cumulative Amount Excreted in Feces
Time frame: Up to Day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HOPO 14-1 in people with Toxicity;Chemical, run by SRI International at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with One or More Adverse Events (time frame: Up to 14 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Nov 2025.