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

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.

Inclusion criteria

• 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.

Exclusion criteria

• 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.
• 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