Study of Single Oral Doses of HOPO 14-1 Evaluating Safety, Tolerability, Pharmacokinetics

NCT05628961 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: SRI-HOPO-01
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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. The study hypothesis is that a single dose of HOPO 14-1 will be safe and tolerable up to 7500 mg.

Conditions

Toxicity;Chemical

Keywords

Internal Radionuclide Contamination

Outcome Measures

Primary Outcomes (4)

• Number of Participants with One or More Adverse Events

  Up to 14 days

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

  Up to 14 days

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

  Up to 14 days

• Number of Participants with One or More Serious Adverse Events

  Up to 14 days

Secondary Outcomes (9)

• Observed Maximum Plasma Concentration (Cmax)

  Up to Day 7

• Observed Time to Reach Cmax (Tmax)

  Up to Day 7

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

  Up to Day 7

• Extrapolated to Infinity (AUC0-inf)

  Up to Day 7

• Terminal Half-Life (t 1/2)

  Up to Day 7

Study Arms (7)

Cohort 1: 100 mg

EXPERIMENTAL

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

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.

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.

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.

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.

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.

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.

Drug: HOPO 14-1

Interventions

HOPO 14-1 DRUG

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.

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

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).
• 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.

Sponsors & Collaborators

• SRI International: lead

Study Sites (1)

SRI International Clinical Trials Unit

Plymouth, Michigan, 48170, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: November 29, 2022
• Study Start: March 15, 2023
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: November 14, 2025

Record last verified: 2025-11

Locations

US (1)